Asacol Acute Diverticulitis(DIVA)Study | NCT00554099

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Days 1 thru Days 10 to 14 (Visit 2): daily antibiotic therapy, dietary advice, and 6 placebo tablets (matching mesalamine) once a day. Visit 2 thru Week 12 : 1 placebo capsule (matching probiotic) and 6 placebo tablets (matching mesalamine) daily.	Drug: Placebo Other: Dietary Advice Drug: Antibiotic for Diverticulitis
Mesalamine	Active Comparator	Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once a day. Visit 2 thru Week 12: 1 placebo capsule (matching probiotic) and 6 - 400 mg mesalamine tablets daily.	Drug: Mesalamine Other: Dietary Advice Drug: Antibiotic for Diverticulitis
Mesalamine & Probiotic	Active Comparator	Days 1 thru 10-14 (Visit 2): daily antibiotic therapy, dietary advice and 6 - 400 mg mesalamine tablets once daily. Visit 2 thru Week 12: 1- Bifidobacterium infantis 35624 capsule and 6 - 400 mg mesalamine tablets daily	Drug: Probiotic Other: Dietary Advice Drug: Antibiotic for Diverticulitis

Name	Type	Description	Arm Group Labels	Other Names
Mesalamine	Drug	6 - 400 mg tablets once daily	Mesalamine
Probiotic

Measure	Description	Time Frame
Global Symptom Score (GSS) at Week 12, Primary Efficacy Population	GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).	12 Weeks

Measure	Description	Time Frame
Percentage of Responders at Week 12 - ITT Population	Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A clinical diagnosis of acute diverticulitis
Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception [at least 3 months prior to enrollment]; 2-barrier methods [e.g., condom, diaphragm, or spermicide]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
Willing and able to participate in the study and provide a signed informed consent

Exclusion Criteria:

Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
Active or recent history (within 6 months) of a peptic ulcer;
Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
History of major abdominal surgery (as determined by the Investigator);
History of GI surgery within 3 months of diagnosis of acute diverticulitis;
History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
If female patient, active or recent history of endometriosis or dysmenorrhea;
Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;

Name	Affiliation	Role
Ana Balske, MD, PhD	Procter and Gamble	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Tucson	Arizona		United States
Research Facility

PubMed Identifier	Type	Citation	Retractions
23426454	Derived	Stollman N, Magowan S, Shanahan F, Quigley EM; DIVA Investigator Group. A randomized controlled study of mesalamine after acute diverticulitis: results of the DIVA trial. J Clin Gastroenterol. 2013 Aug;47(7):621-9. doi: 10.1097/MCG.0b013e31828003f6.

ID	Title	Description
FG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
FG001	Mesalamine	400 mg mesalamine (6 tablets daily)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Global Symptom Score (GSS) at Week 12, Primary Efficacy Population

GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

Primary Efficacy Population - Subset of ITT population including only patients with GSS value at Week 12 and baseline GSS of at least 12.

Posted

Mean

Standard Error

Scores on a Scale

12 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants	OG00041 OG00140 OG00236

Title

Denominators

Categories

Title	Measurements
	OG0007.3± 1.30 OG0014.4± 1.07 OG0025.9± 1.16

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	It was assumed that the placebo treatment group and mesalamine treatment group would have an average composite score of 8.4 and 5.88 at Week 12, respectively. The common standard deviation was set to 4.5 based on the 2 standard deviation rule. Based on these assumptions, 60 patients per treatment group required to detect 30% treatment difference at 1-sided, 0.1 level of significance, with 80% power.	ANCOVA	Fixed effects for treatment, number of diverticulitis attacks and baseline value as covariate.	0.3781		Mean Difference vs. Placebo	-3.0	Standard Error of the Mean	1.69	1-Sided	90		-0.809				No

Secondary

Percentage of Responders at Week 12 - ITT Population

Responder - patient whose GSS scores for all symptoms were either 0 or 1 GSS - Abdominal Pain & Symptom Rating, scale 0-none (better) to 6-severe (worse) for each of the following categories: abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus in stool, feeling urge to evacuate but no bowel movement, painful straining with bowel movement, pain/difficulty urinating. Total minimum score 0 (better), total maximum score 60 (worse).

ITT Population

Posted

Number

Percentage of Participants

12 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants

Secondary

Percentage of Responders at Week 52 - ITT Population

ITT Population

Posted

Number

Percentage of Participants

52 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants

Secondary

Change in GSS From Baseline to Week 12 - ITT Population

ITT Population

Posted

Mean

Standard Error

Scores on a Scale

Baseline to Week 12

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants

Secondary

Change in GSS From Baseline to Week 52 - ITT Population

ITT Population

Posted

Mean

Standard Error

Scores on a Scale

Baseline to Week 52

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants

Secondary

Withdrawal Due to Surgery for Diverticulitis, Percentage, ITT Population, Week 12

ITT Population

Posted

Number

Percentage of Participants

12 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants	OG000

Secondary

Recurrent Diverticulitis, Percentage, ITT Population, Week 12

At least one report of recurrent diverticulitis since the last visit (prior to the Week 12 visit).

ITT Population

Posted

Number

Percentage of Participants

12 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants	OG000

Secondary

Recurrent Diverticulitis, Percentage, ITT Population, Week 52

At least one report of recurrent diverticulitis since the last visit (prior to the Week 52 visit).

ITT Population

Posted

Number

Percentage of Participants

52 Weeks

ID	Title	Description
OG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
OG001	Mesalamine	400 mg mesalamine (6 tablets daily)
OG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Distension	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Benign Ovarian Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Bronchopneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Colon Operation	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Diverticulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Gastritis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Syncope	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG00114 events12 affected40 at risk EG0025 events4 affected36 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0004 events3 affected41 at risk EG0010 events0 affected40 at risk EG0022 events2 affected36 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Abdominal Tenderness	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Anal Pruritis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Angina Pectoris	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected41 at risk EG0011 events1 affected40 at risk EG0023 events2 affected36 at risk
Bartholin's Cyst	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Blood Creatinine Increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Blood Pressure Increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Blood Urea Increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
C-Reactive Protein Increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0021 events1 affected27 at risk
Clostridial Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Colectomy	Surgical and medical procedures	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Colonic Polyp	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 events5 affected41 at risk EG0014 events3 affected40 at risk EG0023 events3 affected36 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0012 events2 affected40 at risk EG0020 events0 affected36 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected41 at risk EG0017 events4 affected40 at risk EG0023 events3 affected36 at risk
Diverticulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Dyslipidaemia	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Fatigue	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0022 events2 affected36 at risk
Feeling Abnormal	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Flushing	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Folliculitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Fungal Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0021 events1 affected27 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0013 events3 affected40 at risk EG0020 events0 affected36 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Herpes Zoster	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Hypokalaemia	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Influenza	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Irritability	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Joint Sprain	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Liver Function Test Abnormal	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Localized Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0002 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Malaise	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 events2 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 events4 affected41 at risk EG0011 events1 affected40 at risk EG0021 events1 affected36 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Obstructive Airways Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Oedema	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0023 events3 affected36 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Perirectal Abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0003 events3 affected29 at risk EG0011 events1 affected32 at risk EG0022 events2 affected27 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0012 events1 affected40 at risk EG0020 events0 affected36 at risk
Rash Generalized	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0011 events1 affected40 at risk EG0020 events0 affected36 at risk
Renal Cyst	Renal and urinary disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Restlessness	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Sciatica	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected32 at risk EG0021 events1 affected27 at risk
Sinusitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0021 events1 affected27 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Tongue Dry	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0020 events0 affected36 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0011 events1 affected32 at risk EG0022 events2 affected27 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected40 at risk EG0021 events1 affected36 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected29 at risk EG0010 events0 affected32 at risk EG0020 events0 affected27 at risk
Vaginal Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected32 at risk EG0020 events0 affected27 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected40 at risk EG0021 events1 affected36 at risk

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D019804	Mesalamine
D019936	Probiotics
D015596	Nutrition Assessment
D000900	Anti-Bacterial Agents

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000636	Aminosalicylic Acids
D012459	Salicylates
D062385	Hydroxybenzoates
D006880	Hydroxy Acids
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D015991	Epidemiologic Measurements
D011634	Public Health
D004778	Environment and Public Health
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

ID	Title	Description
BG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)
BG001	Mesalamine	400 mg mesalamine (6 tablets daily)
BG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo tablets (matching mesalamine, 6 tablets daily)	6	41	32	41
EG001	Mesalamine	400 mg mesalamine (6 tablets daily)	5	40	37	40
EG002	Mesalamine & Probiotic	400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)	0	36	26	36