Gut Transit Effect on Enterohepatic Circulation
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|ClinicalTrials.gov Identifier: NCT03501498|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2018
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intestinal Transit||Drug: Loperamide Drug: Senna||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds|
|Estimated Study Start Date :||April 30, 2018|
|Estimated Primary Completion Date :||June 3, 2018|
|Estimated Study Completion Date :||June 3, 2019|
Slows intestinal transit time
Alters intestinal transit time.
Speeds up intestinal transit time
Alters intestinal transit time.
- 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
- Stool bacterial count [ Time Frame: 7 days ]Bacterial count
- 1. common stool test [ Time Frame: 7 days ]calprotectin
- 2. common stool test [ Time Frame: 7 days ]elastase
- 3. common stool test [ Time Frame: 7 days ]lactoferrin
- Volatile Organic Compounds [ Time Frame: 5 days ]VOC estimation in urine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501498
|Contact: Stephen Lewis, MD||01752 firstname.lastname@example.org|
|Contact: Chris Rollinson, PhDemail@example.com|
|Plymouth, United Kingdom|
|Principal Investigator:||Stephen Lewis, MD||University Hospital Plymouth NHS Trust|