We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gut Transit Effect on Enterohepatic Circulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03501498
Recruitment Status : Completed
First Posted : April 18, 2018
Last Update Posted : September 30, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE April 18, 2018
Last Update Posted Date September 30, 2022
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date May 7, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gut Transit Effect on Enterohepatic Circulation
Official Title  ICMJE The Effect of Intestinal Transit on the Entrohepatic Circulation of Bile Salts, Faecal Microbiome and Production of 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Intestinal Transit
Intervention  ICMJE
  • Drug: Loperamide
    Alters intestinal transit time.
  • Drug: Senna
    Alters intestinal transit time.
Study Arms  ICMJE
  • Experimental: loperamide
    Slows intestinal transit time
    Intervention: Drug: Loperamide
  • Experimental: senna
    Speeds up intestinal transit time
    Intervention: Drug: Senna
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
16
Actual Study Completion Date  ICMJE March 1, 2022
Actual Primary Completion Date May 7, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03501498
Other Study ID Numbers  ICMJE 16/P/138
221556 ( Other Identifier: Integrated Research Application System (IRAS) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University Hospital Plymouth NHS Trust
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Plymouth NHS Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Lewis, MD University Hospital Plymouth NHS Trust
PRS Account University Hospital Plymouth NHS Trust
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP