Next Generation ORS: Comparing ORS With Calcium vs Standa... | NCT05814042

ID	Type	Description	Link
1R21AI169282-01A1	U.S. NIH Grant/Contract		View source

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Next Generation ORS: Comparing ORS With Calcium vs Standa... | NCT05814042 | Trialant

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrient based intervention	Experimental	Nutrition supplement used to stop diarrhea	Drug: Next Generation ORS (oral rehydration solution) (including placebo
Standard of Care oral rehydration solution	Active Comparator	Standard of care nutrition supplement used to stop diarrhea.	Drug: Current standard control ORS (oral rehydration solution)

Name	Type	Description	Arm Group Labels	Other Names
Next Generation ORS (oral rehydration solution) (including placebo	Drug	Nutrition used to stop diarrhea	Nutrient based intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool Output	Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.	Day 1, day 2, Day 3, and entire 3 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of Diarrhea	Duration of diarrhea was the time (in hour) from randomization until cessation of diarrhea	from randomization to end of treatment at day 3
Stool Frequency	Daily stool frequency was defined as the total number of diarrhea stools passed during a given 24-hour intervention day.

Contacts/Locations Module

Name	Affiliation	Role
Sam Cheng, MD. PhD	University of Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ICDDR,B Dhaka Hospital		Dhaka		1212	Bangladesh

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ORS With Calcium (Aim 1)	30 severely dehydrated adult patients infected with V. Cholerae (Rapid diagnostic test (RDT+) (Aim 1) were randomized to receive ORS with calcium (intervention) in hospital for 72 hours or up to the time when the patients fulfil the criteria of cessation of diarrhea.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 16, 2022	Dec 19, 2025

Arm/Group Information

ID	Title	Description
BG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
BG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
BG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
BG003	ORS: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00030 BG00130 BG002167 BG003169 BG004396

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

age of participants

Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00030 ParticipantsBG00130 ParticipantsBG002167 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00030 ParticipantsBG00130 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Weight

Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168

Mean

Standard Deviation

kilogram

Title	Denominators	Categories
	ParticipantsBG00030 ParticipantsBG00130 ParticipantsBG002

Correction by IV fluid (ml)

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00030 ParticipantsBG00130 ParticipantsBG002

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

Stool Output

Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.

The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.

Posted

Mean

Standard Deviation

gram

Day 1, day 2, Day 3, and entire 3 days

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
OG003	ORS: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
OG004	ORS With Calcium: Aim 2 (Severe Diarrhea Subset)	This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., >1,500 mL in the first 8 hours of Day 1), while others had more modest losses. To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight <1,500 g during the first 8 hours of Day 1 or stool weight <50 g/kg/day on Day 1.
OG005	ORS: Aim 2 (Severe Diarrhea Subset)	This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., >1,500 mL in the first 8 hours of Day 1), while others had more modest losses. To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight <1,500 g during the first 8 hours of Day 1 or stool weight <50 g/kg/day on Day 1.
OG006	ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)	This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., >1,500 mL in the first 8 hours of Day 1), while others had more modest losses. To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight <1,500 g during the first 8 hours of Day 1 or stool weight <50 g/kg/day on Day 1.
OG007	ORS: Aim 2 (Non-Severe Diarrhea Subset)	This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., >1,500 mL in the first 8 hours of Day 1), while others had more modest losses. To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight <1,500 g during the first 8 hours of Day 1 or stool weight <50 g/kg/day on Day 1.

Units	Counts
Participants	OG00030 OG00130 OG002167 OG003

Title	Denominators	Categories
Day 1 Stool Output	ParticipantsOG00030 ParticipantsOG00130 ParticipantsOG002167 ParticipantsOG003

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	Stool Output: Day 1	Wilcoxon (Mann-Whitney)		0.9941	A priori threshold for statistical significance (e.g., < 0.05)													Superiority
OG002 OG003	Stool Output: Day 1

Secondary

Duration of Diarrhea

Duration of diarrhea was the time (in hour) from randomization until cessation of diarrhea

Posted

Mean

Standard Deviation

hours

from randomization to end of treatment at day 3

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.

Secondary

Stool Frequency

Daily stool frequency was defined as the total number of diarrhea stools passed during a given 24-hour intervention day.

The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.

Posted

Mean

Standard Deviation

Events

Day 1, Day 2, Day 3

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.

Secondary

Vomiting

Daily volume of vomiting was defined as the total weight of all vomitus (g) during a given 24-hour intervention day.

The number analyzed in individual rows differs from the overall sample size because the number of patients who vomited varies from day to day.

Posted

Mean

Standard Deviation

gram

Day 1, Day 2, Day 3

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.

Secondary

Percentage of Patients Who Require Unscheduled Intravenous Therapy

Percentage of patients who require unscheduled intravenous therapy at Day1, Day 2 and Day 3 following intervention.

Overall might be all participants, while rows are specific treatment arms, some potentially smaller.

Posted

Count of Participants

Participants

Day 1, Day 2, Day 3

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.

Secondary

Intake of ORS

Intake of ORS (ml) from randomization until cessation of diarrhea in Day 1, Day2, and Day 3.

The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.

Posted

Mean

Standard Deviation

Day 1, Day 2, Day 3

ID	Title	Description
OG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
OG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ORS With Calcium: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).	30	0	30	0	30
EG001	ORS: Aim 1	In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration <24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).	30	0	30	0	30
EG002	ORS With Calcium: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.	167	1	167	14	167
EG003	ORS: Aim 2	In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated as ORS) or Standard WHO ORS with 10 mM calcium citrate (designated as ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.	169	1	169	11	169

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hypovolemic shock	Gastrointestinal disorders		Systematic Assessment	Two cases were SAE based on complications. Case one: Diarrhea/shock plus concern for cardiac and diabetes complications. Case two: Diarrhea/shock plus concern for Non-ST-Segment Elevation MI and septic shock. These events were not unexpected.	EG0000 affected30 at risk EG0010 affected30 at risk EG0021 affected167 at risk EG0031 affected169 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
fever	Gastrointestinal disorders	Systematic Assessment	Transient fever was noted in 11 out of 167 in Aim 2 Group ORS with Calcium and 7 out of 169 in Aim 2 Group ORS. No AEs noted in Aim 1. These events were not unexpected.	EG0000 affected30 at risk EG0010 affected30 at risk EG00211 affected167 at risk EG0037 affected169 at risk
Epigastric pain	Gastrointestinal disorders	Systematic Assessment	Per report, transient epigastric pain or discomfort responsive to H2 blocker or omeprazole was noted in 1 out of 167 in Group ORS with Calcium and 3 out of 169 in Group ORS in AIM 2. None were reported in Aim 1 study. These events were not unexpected	EG0000 affected30 at risk EG0010 affected30 at risk EG0022 affected167 at risk EG003
Heartburn	Gastrointestinal disorders	Systematic Assessment	Per report, transient heartburn that is responsive to H2 blocker or omeprazole was noted in 1 out of 167 in Group ORS with Calcium and 3 out of 169 in Group ORS in AIM 2. None were reported in Aim 1 study. These events were not unexpected.	EG0000 affected30 at risk EG0010 affected30 at risk EG0021 affected167 at risk EG003

Title	Organization	Phone	Extension	Email
Sam Cheng	University of Florida	203 687 9807		sam.cheng@ufl.edu

ID	Term
D003967	Diarrhea
D002771	Cholera

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014735	Vibrio Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Day 2 Stool Output

- ParticipantsOG00020
- ParticipantsOG00125
- ParticipantsOG00264
- ParticipantsOG00367
- ParticipantsOG0040
- ParticipantsOG0050
- ParticipantsOG0060
- ParticipantsOG0070

Title	Measurements
	OG000638± 1116 OG001768± 996 OG0021326± 1946 OG003

Day 3 Stool Output

- ParticipantsOG0002
- ParticipantsOG0016
- ParticipantsOG00216
- ParticipantsOG00320
- ParticipantsOG0040
- ParticipantsOG0050
- ParticipantsOG0060
- ParticipantsOG0070

Title	Measurements
	OG000485± 629 OG001360± 356 OG0021156± 1840 OG003

Total stool output

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG002167
- ParticipantsOG003169
- ParticipantsOG00432
- ParticipantsOG00532
- ParticipantsOG006135
- ParticipantsOG007137

Title	Measurements
	OG0005412± 2945 OG0015581± 3046 OG0022308± 3460 OG003

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	Duration of Diarrhea	Wilcoxon (Mann-Whitney)		0.7056	A priori threshold for statistical significance (e.g., < 0.05)													Superiority
OG002 OG003	Duration of Diarrhea	Wilcoxon (Mann-Whitney)		0.5866	A priori threshold for statistical significance (e.g., < 0.05)													Superiority

Title

Denominators

Categories

Stool frequency: Day 1

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG002167
- ParticipantsOG003169
- ParticipantsOG00432
- ParticipantsOG00532
- ParticipantsOG006135
- ParticipantsOG007137

Title	Measurements
	OG00021.4± 9.3 OG00119.0± 8.3 OG0028.8± 7.4 OG003

Stool frequency: Day 2

- ParticipantsOG00020
- ParticipantsOG00125
- ParticipantsOG00264
- ParticipantsOG00367

Stool frequency: Day 3

- ParticipantsOG0002
- ParticipantsOG0016
- ParticipantsOG00216
- ParticipantsOG00320

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Stool Frequency: Day 1	Fisher Exact	0.2733	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Stool Frequency: Day 1	Fisher Exact	0.8642	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG004 OG005	Stool Frequency: Day 1	Fisher Exact	0.0339	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG006 OG007	Stool Frequency: Day 1	Fisher Exact	0.3329	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Stool Frequency: Day 2	Fisher Exact	0.6485	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Stool Frequency: Day 2	Fisher Exact	0.3025	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Stool Frequency: Day 3	Fisher Exact	0.7168	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Stool Frequency: Day 3	Fisher Exact	0.1459	A priori threshold for statistical significance (e.g., < 0.05)	Superiority

Title

Denominators

Categories

Vomiting: Day 1

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG002167
- ParticipantsOG003169

Title	Measurements
	OG000313.5± 495 OG001283± 459 OG002111.4± 311 OG003

Vomiting: Day 2

- ParticipantsOG00020
- ParticipantsOG00125
- ParticipantsOG00263
- ParticipantsOG00364

Vomiting: Day 3

- ParticipantsOG0000
- ParticipantsOG0010
- ParticipantsOG00215
- ParticipantsOG00320

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Vomiting: Day 1	Wilcoxon (Mann-Whitney)	0.7298	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Vomiting: Day 1	Wilcoxon (Mann-Whitney)	0.6305	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Vomiting: Day 2	Wilcoxon (Mann-Whitney)	0.5703	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Vomiting: Day 2	Wilcoxon (Mann-Whitney)	0.0475	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Vomiting: Day 3	Wilcoxon (Mann-Whitney)	0.8452	A priori threshold for statistical significance (e.g., < 0.05)	Superiority

Title

Denominators

Categories

Percentage of patients who require unscheduled intravenous therapy: Day 1

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG002167
- ParticipantsOG003169

Title	Measurements
	OG0004 OG0014 OG0026 OG003

Percentage of patients who require unscheduled intravenous therapy: Day 2

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG00264
- ParticipantsOG003

Percentage of patients who require unscheduled intravenous therapy: Day 3

- ParticipantsOG0003
- ParticipantsOG0017
- ParticipantsOG00214
- ParticipantsOG003

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Percentage of patients who require unscheduled intravenous therapy: Day 1	Fisher Exact	1.000	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Percentage of patients who require unscheduled intravenous therapy: Day 1	Fisher Exact	0.5850	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Percentage of patients who require unscheduled intravenous therapy: Day 2	Fisher Exact	1.000	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Percentage of patients who require unscheduled intravenous therapy: Day 2	Fisher Exact	0.7439	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Percentage of patients who require unscheduled intravenous therapy: Day 3	Fisher Exact	1.00	A priori threshold for statistical significance (e.g., < 0.05)	Superiority

Title

Denominators

Categories

Intake of ORS: Day 1

- ParticipantsOG00030
- ParticipantsOG00130
- ParticipantsOG002167
- ParticipantsOG003169

Title	Measurements
	OG0005107± 1616 OG0015105± 2064 OG0022992± 1786 OG003

Intake of ORS: Day 2

- ParticipantsOG00020
- ParticipantsOG00125
- ParticipantsOG00263
- ParticipantsOG00367

Intake of ORS: Day 3

- ParticipantsOG0002
- ParticipantsOG0016
- ParticipantsOG00216
- ParticipantsOG00320

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Non-Inferiority Type
OG000 OG001	Intake of ORS: Day 1	Wilcoxon (Mann-Whitney)	0.7558	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Intake of ORS: Day 1	Wilcoxon (Mann-Whitney)	0.6308	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Intake of ORS: Day 2	Wilcoxon (Mann-Whitney)	0.1878	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Intake of ORS: Day 2	Wilcoxon (Mann-Whitney)	0.3191	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG000 OG001	Intake of ORS: Day 3	Wilcoxon (Mann-Whitney)	0.2765	A priori threshold for statistical significance (e.g., < 0.05)	Superiority
OG002 OG003	Intake of ORS: Day 3	Wilcoxon (Mann-Whitney)	0.0007	A priori threshold for statistical significance (e.g., < 0.05)	Superiority

ID	Term
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D001779	Blood Coagulation Factors
D001685	Biological Factors

ID	Term
C044142	World Health Organization oral rehydration solution
D002118	Calcium