Gut Transit Effect on Enterohepatic Circulation

September 29, 2022 updated by: University Hospital Plymouth NHS Trust

The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of Volatile Organic Compounds

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: loperamide
Slows intestinal transit time
Alters intestinal transit time.
Experimental: senna
Speeds up intestinal transit time
Alters intestinal transit time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool bacterial count
Time Frame: 7 days
Bacterial count
7 days
1. common stool test
Time Frame: 7 days
calprotectin
7 days
2. common stool test
Time Frame: 7 days
elastase
7 days
3. common stool test
Time Frame: 7 days
lactoferrin
7 days
Volatile Organic Compounds
Time Frame: 5 days
VOC estimation in urine
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stephen Lewis, MD, University Hospital Plymouth NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Actual)

May 7, 2018

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/P/138
  • 221556 (Other Identifier: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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