Gut Transit Effect on Enterohepatic Circulation

• ClinicalTrials.gov Identifier: NCT03501498
• Recruitment Status: Completed
• First Posted: April 18, 2018
• Last Update Posted: September 30, 2022
• Sponsor: University Hospital Plymouth NHS Trust
• Information provided by (Responsible Party): University Hospital Plymouth NHS Trust

Tracking Information

• First Submitted Date: April 10, 2018
• First Posted Date: April 18, 2018
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: April 10, 2017
• Actual Primary Completion Date: May 7, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gut Transit Effect on Enterohepatic Circulation
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Intestinal Transit

Intervention

• Drug: Loperamide
  Alters intestinal transit time.
• Drug: Senna
  Alters intestinal transit time.

Study Arms

• Experimental: loperamide
  Slows intestinal transit time
  Intervention: Drug: Loperamide
• Experimental: senna
  Speeds up intestinal transit time
  Intervention: Drug: Senna

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 29, 2019): 19
• Original Estimated Enrollment (submitted: April 10, 2018): 16
• Actual Study Completion Date: March 1, 2022
• Actual Primary Completion Date: May 7, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03501498
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: University Hospital Plymouth NHS Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital Plymouth NHS Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital Plymouth NHS Trust
• Verification Date: October 2021