Clinical trial NCT03501498: Gut Transit Effect on Enterohepatic Circulation
Official title: The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Transit
Keywords: Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised cross-over study. Volunteers will be assessed at baseline, then after either taking loperamide or senna at the maximally tolerated dose for 2 days prior to the 'assessment period' then during the assessment period (5-7 days). After a washout period of at least 21 days, volunteers will then repeat the same assessments but cross over to take the second drug either loperamide or senna.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of intestinal transit on faecal bile acids
timeFrame: 7 days
Secondary outcomes:
measure: Stool bacterial count
timeFrame: 7 days
measure: 1. common stool test
timeFrame: 7 days
measure: 2. common stool test
timeFrame: 7 days
measure: 3. common stool test
timeFrame: 7 days
measure: Volatile Organic Compounds
timeFrame: 5 days
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: Stephen Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: