- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03501498
Gut Transit Effect on Enterohepatic Circulation
The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The digestion of food by human body starts from oral cavity and continues until its excreted as faeces. There are different factors affecting this process. Important factors are movement through the GI Tract, breakdown of food material and absorption by the body to produce energy. The unabsorbed waste material is then excreted by the body.
Different enzymes are produced by human body which are responsible for digestion of food. One important chemical is bile which is produced in the gall bladder. It is important in digestion of fatty foods but affects the movement of food material as well. There are numerous bacteria present in human GI tract especially in mouth and large bowel which also play an important role in process of digestion of food.
Different conditions of health and disease can affect how food moves through the GI tract (known as intestinal transit). It also affects the activity of different digestive enzymes and chemicals in body. The bacterial population in the body is also affected by changes described above. The purpose of this study is to observe how these different processes especially the intestinal transit, bile salts and gut bacteria affect each other. This will help to identify mechanisms responsible for different disorders of human gut like irritable bowel syndrome. The study is part of an effort to identify new and future treatment of these conditions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Plymouth, United Kingdom
- Derriford Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- • Healthy volunteers between the ages of 18 and 65
Exclusion Criteria:
- Unable to consent
- Pregnant or lactating
- Known diarrhoeal disorder
- Known constipation.
- Any gastrointestinal disease or previous gastric surgery
- An episode of gastroenteritis within the last month
- Taking any acid suppressing medication
- Any significant medical condition (e.g. diabetes, renal disease)
- Any antibiotic intake within the last one-month
- Any drug with known effects on GI motility
- Known allergy or intolerance to senna or loperamide
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: loperamide
Slows intestinal transit time
|
Alters intestinal transit time.
|
Experimental: senna
Speeds up intestinal transit time
|
Alters intestinal transit time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effect of intestinal transit on faecal bile acids
Time Frame: 7 days
|
Change in bile acid pool and activity from baseline with each intervention
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stool bacterial count
Time Frame: 7 days
|
Bacterial count
|
7 days
|
1. common stool test
Time Frame: 7 days
|
calprotectin
|
7 days
|
2. common stool test
Time Frame: 7 days
|
elastase
|
7 days
|
3. common stool test
Time Frame: 7 days
|
lactoferrin
|
7 days
|
Volatile Organic Compounds
Time Frame: 5 days
|
VOC estimation in urine
|
5 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephen Lewis, MD, University Hospital Plymouth NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/P/138
- 221556 (Other Identifier: Integrated Research Application System (IRAS))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of British ColumbiaCompleted
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AstraZenecaCompletedFood Effect | Gastric Emptying Time | Magnetic Marker Monitoring | Gastrointestinal-transport | Small Intestinal Transit Time | Time for Colon ArrivalGermany
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Uppsala UniversityUnknown
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Clinical Trials on Loperamide
-
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Marin GolčićUnknownColorectal Cancer MetastaticCroatia
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Tianjin Medical University Cancer Institute and...Recruiting
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-
University Hospital, Strasbourg, FranceIpsenTerminatedHigh Output StomaFrance
-
Eastern Cooperative Oncology GroupNational Cancer Institute (NCI); Cancer and Leukemia Group B; SWOG Cancer Research...CompletedDiarrhea | Colorectal CancerUnited States