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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intestinal Transit Drug: Loperamide Drug: Senna Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: loperamide
Slows intestinal transit time
Drug: Loperamide
Alters intestinal transit time.

Experimental: senna
Speeds up intestinal transit time
Drug: Senna
Alters intestinal transit time.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Stool bacterial count [ Time Frame: 7 days ]
    Bacterial count

  2. 1. common stool test [ Time Frame: 7 days ]
    calprotectin

  3. 2. common stool test [ Time Frame: 7 days ]
    elastase

  4. 3. common stool test [ Time Frame: 7 days ]
    lactoferrin

  5. Volatile Organic Compounds [ Time Frame: 5 days ]
    VOC estimation in urine



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Stephen Lewis, MD 01752 431117 stephenlewis1@nhs.net
Contact: Chris Rollinson, PhD 01752431045 crollinson@nhs.net

Locations
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United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
Investigators
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Principal Investigator: Stephen Lewis, MD University Hospital Plymouth NHS Trust

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Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT03501498     History of Changes
Other Study ID Numbers: 16/P/138
221556 ( Other Identifier: Integrated Research Application System (IRAS) )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Plymouth NHS Trust:
Intestinal Transit, Bile Salts, Gut Bacteria, Volatile Organic Compounds

Additional relevant MeSH terms:
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Loperamide
Antidiarrheals
Bile Acids and Salts
Gastrointestinal Agents