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Constipation is a prevalent gastrointestinal condition. Beyond simple lifestyle measures (e.g. increasing fibre intake, hydration, levels of exercise), medical therapies are available for management. However, a sizeable number of sufferers are dissatisfied with drug treatments (either over-the-counter or prescribed), meaning there is an unmet need for alternative therapeutic strategies.
Pre, pro- and synbiotics have emerged as one alternative treatment, and a growing body of evidence now supports their use in a proportion of individuals with mild constipation. However, it is currently not possible to predict which individuals may benefit. A better understanding of an individuals' symptoms and underlying pathophysiology may allow for more targeted treatment.
The multistrain live bacterial food product (probiotic) being tested contains billions of live and active bacteria that has been shown to improve symptoms in the irritable bowel syndrome (IBS: which is 'constipation-predominant' in many). Notably, improvements ('completely resolved' or 'some positive difference') in bowel habit satisfaction, abdominal pain, bloating and urgency, as well as on quality of life have been shown after 4 or more weeks of this probiotc.
This study aims to have 20 participants with self-reported constipation to assess improvements in constipation symptoms, quality of life and measures of gut function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-strain Liquid Probiotic | Experimental | 70ml of a multi-strain liquid probiotic taken daily for 28-35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-strain probiotics | Dietary Supplement | 28-35 days of 70 ml Symprove once daily, to be taken on an empty stomach upon waking. 10 minutes should be taken between ingestion of Symprove before eating and drinking. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Constipation-Symptoms (PAC-SYM) | Number of participants with clinically meaningful change in PAC-SYM score (reduction of >0.6 or >0.75 points). The PAC-SYM questionnaire is a 12 item validated patient-reported measure of severity of constipation symptoms during the past two weeks. | Pre-post comparison (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment of Constipation - Quality of Life (PAC-QoL) | Number of participants with clinically meaningful change in PAC-QoL (reduction of >0.5 or >1.0 point). A validated questionnaire consisting of 28 items to measure the impact of constipation on a patient's quality of life. | Pre-Post comparison (28 days) |
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Inclusion Criteria:
Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
Participant has Cleveland Clinic constipation score (CCCS) of 9-16 at screening call
Participant is willing to discontinue all other therapies for constipation and undergo washout where applicable.
Participant is a male or non-pregnant female and is 18-70 years of age
If WOCBP participant is willing to adhere to one of the following methods of contraception:
i) Hormonal contraception e.g. the 'pill' or an implant ii) Intrauterine device (IUD) iii) Intrauterine hormone-releasing system (IUS) vi) Sexual abstinence (if it is in line with participants' preferred and usual lifestyle).
or has had a: v) Hysterectomy or has a: vi) Vasectomised partner
Participant can communicate well with the Investigator and to comply with the requirements for the entire study.
Participant has capacity to understand written English.
Participant has a body mass index (BMI) of 18.5 - 39.9kg/m2 (bounds included).
Participant agrees to follow all pre-test preparation for the ATMO capsule transit study.
Exclusion Criteria:
Women who are pregnant and/or breastfeeding.
Participants who are planning to significantly change their diet (e.g. weight loss program, becoming vegetarian) during the study period.
Participant has had diarrhoea within 7 weeks of screening period.
Prior abdominal surgery involving resection of the small or large bowel.
Prior bariatric surgery involving resection of the stomach or by-pass procedures.
Type 1 diabetes mellitus.
Known organic or structural GI disease including:
Irritable bowel syndrome where the predominant symptom is pain (assessed via screening questions).
Oropharyngeal dysphagia or difficulty swallowing capsules.
Any other medical condition that the investigator deems may confound results or affect participants' safety in the study.
Any use of prohibited medication that the participant cannot complete appropriate washout for.
Insufficient knowledge of English to complete the daily bowel diary.
Allergy to any component of the supplement, motility bar, lactulose or Zoe blue cookie.
Participant is involved in this study as an investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
Previous use of the probiotic Symprove.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fay Rendall | Contact | +441613027777 | research@thefunctionalgutclinic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Functional Gut Clinic | Recruiting | London | NW1 6PU | United Kingdom |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The study is a single arm open label treatment. The study comprises of a 2 week baseline period followed by a 4 week treatment period.
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| Participant Compliance |
Number of participants completing >75% of breath gas measurements and bowel diary submissions with OMED device. The OMED Health Breath Analyzer is used for breath gas readings at 4 intervals during the day. The bowel diary recorded daily on paper throughout the study capturing movements, symptoms and any medication |
| Pre-Post comparison (28 days) |
| Whole Gut Transit Time (ATMO) | Change in whole gut transit time measured by ATMO capsule ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract. | Pre-Post comparison (28 days) |
| Whole Gut Transit Time (Blue-dye) | Change in whole gut transit time measured by Blue dye transit study baseline period to treatment period. Participants are required to consume a Zoe blue cookie the following morning after both visits 2 and 3. Participants then report when the blue food colour is visible in their stool, checking every time they pass a bowel movement. | Pre-Post comparison (28 days) |
| Small Bowel Transit Time (ATMO) | Change in small bowel transit time measured by ATMO capsule ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract. | Pre-Post comparison (28 days) |
| Large Bowel Transit Time (ATMO) | Change in large bowel transit time measured by ATMO capsule ATMO capsule is an ingestible electronic medical device measuring gastrointestinal (GI) transit time and environmental conditions as it moves through the digestive tract. | Pre-Post comparison (28 days) |
| Gastrointestinal Symptom Rating Scale (GSRS) | Mean change in GSRS score A validated questionnaire consisting of 15items to assess range of GI symptoms. Scored using a seven-graded Likert scale, where 1 represents the most positive option and 7 the most negative one. | Pre-Post comparison (28 days) |
| Stool form comparison | Average stool type recorded in two week baseline compared to average stool type recorded final two weeks of treatment period. Measured using the bristol stool chart reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 29-42) |
| Stool frequency comparison | Average stool frequency recorded in two week baseline compared to average stool type recorded final two weeks of treatment period reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 29-42) |
| Hydrogen and methane production | Assessment of longitudinal hydrogen and methane production during baseline and treatment periods. Recorded by OMED device 4x daily | Pre-Post comparison (days 1-14 compared to days 15-42) |
| Global PAC-SYM | Comparison of global PAC-SYM score from baseline period to treatment period. | Pre-Post comparison (28 days) |
| Inidividual PAC-SYM | Comparison of individual PAC-SYM symptom scores from baseline period to treatment period. | Pre-Post comparison (28 days) |
| Straining | Self reported straining recorded in two week baseline compared to self reported straining during treatment period reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 15-42) |
| Sense of complete evacuation | Self reported sense of complete evacuation recorded in two week baseline compared to self reported Sense of complete evacuation during treatment period reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 15-42) |
| Time taken for evacuation | Self reported time taken for evacuation recorded in two week baseline compared to self reported time taken for evacuation during treatment period reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 15-42) |
| Rescue Medication | Self reported use of rescue medication recorded in two week baseline compared to self reported use of rescue medication during treatment period reported in bowel habit diary. | Pre-Post comparison (days 1-14 compared to days 15-42) |