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The Impact of "Crohn's Disease-TReatment-with-EATing" Diet and Exclusive Enteral Nutrition on Healthy Gut Bacteria

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ClinicalTrials.gov Identifier: NCT02426567
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Konstantinos Gerasimidis, University of Glasgow

Brief Summary:

Current evidence suggests that the gut microbiota and dietary influences are as important as genetics in the aetiology of Crohn's disease (CD). We have recently shown that disease improvement, following treatment with Exclusive Enteral Nutrition (EEN), coincided with changes in the gut microbiota.

The main purposes of this study are: a) to explore whether the gut microbiota changes we observed in this previous study in children with CD during EEN are disease specific or not, and b) to develop a novel food-based diet (Crohn's Disease TReatment-with-EATing/CD-TREAT diet) which will induce changes to the metabolic activity and bacterial composition of the gut microbiota of healthy people, similar to those seen on EEN, the first-line treatment for active paediatric CD.

This study will produce high quality scientific evidence to move the CD-TREAT diet towards a preliminary clinical trial in patients with CD which is currently inappropriate and unethical to carry out in people with active CD undertaking contemporary medical treatment.


Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Modification Other: Exclusive Enteral Nutrition (EEN) Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Exploratory Study on the Impact of a Food-based Restrictive Diet (Crohn's Disease-TReatment-with EATing/CD-TREAT Diet) and Liquid Exclusive Enteral Nutrition (EEN) on Healthy Gut Microbiota Composition and Metabolic Activity
Study Start Date : November 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Healthy Adult Participants A
Participants who will get two interventional diets, for 7 days each, but allocated to start with Exclusive Enteral Nutrition (EEN)
Other: Exclusive Enteral Nutrition (EEN)
One week course of an isocaloric exclusive milk-based diet

Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)
One week course of an isocaloric, exclusion food-based diet

Experimental: Healthy Adult Participants B
Participants who will get two interventional diets, for 7 days each, but allocated to start with Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)
Other: Exclusive Enteral Nutrition (EEN)
One week course of an isocaloric exclusive milk-based diet

Other: Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)
One week course of an isocaloric, exclusion food-based diet




Primary Outcome Measures :
  1. Gut Bacterial Composition [ Time Frame: 12 months ]
    Gut microbiota composition measured by 16S rRNA gene amplicon sequencing, whole genome shotgun metagenomics and qPCR of selective bacterial species previously implicated in the onset of CD (e.g. Escherichia coli, Faecalibacterium prausnitzii, Bifidobacterium spp)

  2. Gut Bacterial Metabolites [ Time Frame: 12 months ]
    Gut microbiota metabolic activity as a measure of short chain fatty acids, hydrogen sulfide, lactate, ammonia and pH levels


Secondary Outcome Measures :
  1. Dietary Intake [ Time Frame: 12 months ]
    Dietary intake measured by a 7-day estimated dietary record



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult people
  2. Normal weight (Body Mass Index: 18-25kg/m^2)
  3. Stable weight the past month

Exclusion Criteria:

  1. Acute or chronic illness (defined as illness which requires regular visits to health services)
  2. Positive or negative energy balance (recent weight gain or loss, ±2 Kg the past month)
  3. History of gut surgery
  4. Use of antibiotics or steroids the last 3 months

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): NCT02426567


Locations
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United Kingdom
School of Medicine, University of Glasgow / New Lister Building, Glasgow Royal Infirmary
Glasgow, United Kingdom, G312ER
Sponsors and Collaborators
University of Glasgow
Investigators
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Principal Investigator: Konstantinos Gerasimidis, BSc MSc PhD University of Glasgow

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Konstantinos Gerasimidis, Lecturer in Clinical Nutrition, University of Glasgow
ClinicalTrials.gov Identifier: NCT02426567     History of Changes
Other Study ID Numbers: 200130161
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr Konstantinos Gerasimidis, University of Glasgow:
Crohn's Disease
Exclusive Enteral Nutrition
Dietary Treatment
Gut microbiota

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases