Gut Transit Effect on Enterohepatic Circulation

Not Applicable

Completed

• Conditions: Intestinal Transit
• Interventions: Drug: Loperamide; Drug: Senna

• Registration Number: NCT03501498
• Lead Sponsor: University Hospital Plymouth NHS Trust

Brief Summary

A study to determine the influence of changing intestinal transit time of the enterohepatic recirculation of bile acids.

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 Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Primary Completion: 2018-05-07
• Status Verified: 2021-10
• Study Completion: 2022-03-01
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
loperamide	Loperamide	Slows intestinal transit time
senna	Senna	Speeds up intestinal transit time

Primary Outcome Measures

Name	Time	Method
The effect of intestinal transit on faecal bile acids	7 days	Change in bile acid pool and activity from baseline with each intervention

Secondary Outcome Measures

Name	Time	Method
1. common stool test	7 days	calprotectin
Stool bacterial count	7 days	Bacterial count
2. common stool test	7 days	elastase
3. common stool test	7 days	lactoferrin
Volatile Organic Compounds	5 days	VOC estimation in urine

Trial Locations

Locations (1)

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom