Intestinal Transit
Conditions
Keywords
Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds
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.
Interventions
DRUGLoperamide
Alters intestinal transit time.
DRUGSenna
Alters intestinal transit time.
Sponsors
University Hospital Plymouth NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of intestinal transit on faecal bile acids | 7 days | Change in bile acid pool and activity from baseline with each intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stool bacterial count | 7 days | Bacterial count |
| 1. common stool test | 7 days | calprotectin |
| 2. common stool test | 7 days | elastase |
| 3. common stool test | 7 days | lactoferrin |
| Volatile Organic Compounds | 5 days | VOC estimation in urine |
Countries
United Kingdom
Outcome results
None listed