Skip to main content
OpenTrials
Completed

NCT Number: NCT02920294

Modulation of Microbial Composition in Ileostomy Patients

To determine the small intestinal microbiota response in humans to dietary interventions for two consecutive weeks, and to relate this to parameters of intestinal barrier function and immune and metabolic responses in blood, as functional outcome parameters of host physiology

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, Limburg, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Ileostomy installed at least 3 years prior to participation
  • Free of any complications originating from the colectomy procedure for at least 1 yr prior to participation, with the exception of possible skin irritation at the location of the stoma
  • BMI from 18 till 28 kg/m2
  • Age from 18 till 70 years
  • Available for entire study protocol.
  • For female: If of child bearing potential, female subjects must be using or complying with methods of contraception (such as oral birth control pills, intra-uterine device, double barrier methods (like condoms and spermicide, etc.)

Exclusion criteria

  • • History of cardiovascular, respiratory, urogenital, hepatic, haematological / immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, laboratory assessments which might limit participation in or completion of the study protocol, and/or major surgery with the exception of total colectomy, hysterectomy and/or appendectomy.
  • Subject with known lactose intolerance or with known or suspected allergy or hypersensitivity to any component of the study product(s) (milk protein for example) + sucrose + rhamnose
  • Severe gastrointestinal symptoms. In case of mild gastrointestinal symptoms, the principal investigator and the medically responsible MD will judge eligibility to participate.
  • Removal of more than 15 cm of the ileum during or at any moment after the colectomy procedure
  • Abdominal surgery interfering with gastrointestinal function, upon judgment of the principal investigator and the medically responsible MD
  • Use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (but except oral contraceptives), within 14 days prior to and during participation.
  • Consumption of any probiotic or prebiotic supplements or pre- and probiotics containing food products, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principal investigator), in the 4 weeks prior to the study and during study participation (E4 PreProbiotics).
  • Use of antibiotics in the 4 weeks prior to the start of study and during study participation
  • Prohibited use of pro-, pre- or synbiotics during study period and three months prior to start of study. A list with forbidden products will be provided'
  • History of any side effects towards intake of pro- or prebiotic supplements of any kind.

Treatment and study plan

Probiotic 1

Dietary Supplement

Fresh fermented dairy drink containing yoghurt ferments

Probiotic 2

Dietary Supplement

Fresh fermented dairy drink containing probiotic strain

Placebo

Dietary Supplement

Acidified dairy drink without ferments

Primary outcomes

  1. Temporal microbial composition and activity in the small intestine in ileal effluent

    Time frame: 2 weeks intervention

    The microbiome activity will be determined as a function of the diet by double strand cDNA production and random sequencing of mRNA enriched fractions of total effluent RNA obtained from the effluent samples at the start and end of each intervention period.

Secondary outcomes

  1. Small intestinal permeability by a multi sugar test (urinary recovery of test sugars)

    Time frame: 2 weeks intervention

  2. Gene transcription response in blood by transcriptome patterns.

    Time frame: 2 weeks intervention

    Transcriptome patterns will be determined in peripheral blood mononuclear cells obtained from blood samples from the participating ileostoma patients

  3. The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status

    Time frame: 2 weeks intervention

    A panel of biomarkers will be determined in peripheral blood obtained at the start and end of the intervention periods

  4. The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo

    Time frame: 2 weeks intervention

    Peripheral whole blood immune responsiveness towards a subset of bacterial immune-stimuli will be assessed using the standardized truculture system

  5. Morning urine metabolome profiles

    Time frame: 2 weeks intervention

    The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.

  6. Peripheral blood metabolome profiles

    Time frame: 2 weeks intervention

    The principal analytical methodology employed is mass-spectrometry profiling and can commonly provide reliable quantifications of more than 400 named-metabolites in different body-fluid samples.

  7. The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates)

    Time frame: 2 weeks intervention

  8. Short chain fatty acid profiles in ileal effluent

    Time frame: 2 weeks intervention

  9. Number of participants with Gastrointestinal symptoms by Visual Analogue Scales

    Time frame: 2 weeks intervention

  10. Occurrence and severity of treatment related adverse events

    Time frame: 2 weeks intervention

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Modulation of Small Intestinal Microbial Composition and Activity,Systemic Immune Adaptation and Blood Transcriptional Changes Induced by 2-wks Consumption With 2 Fermented Milk Products;a Randomized,Exploratory,Cross-over,Double Blind,Controlled Study in Ileostomy Patients

Acronym: INSIDE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.