Modulation of Microbial Composition in Ileostomy Patients

NCT02920294 | Completed

• 1 other identifier: METC 163023
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ileostomy - Stoma

Keywords

probiotics, microbiota, ileostoma

Outcome Measures

Primary Outcomes (1)

• Temporal microbial composition and activity in the small intestine in ileal effluent

  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.

  2 weeks intervention

Secondary Outcomes (10)

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

  2 weeks intervention

• Gene transcription response in blood by transcriptome patterns.

  2 weeks intervention

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

  2 weeks intervention

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

  2 weeks intervention

• Morning urine metabolome profiles

  2 weeks intervention

Study Arms (3)

Probiotic 1

ACTIVE COMPARATOR

Fresh fermented dairy drink containing yoghurt ferments consumed as follows: one bottle (100g) OD for 14 consecutive days

Dietary Supplement: Probiotic 1

Probiotic 2

ACTIVE COMPARATOR

Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) OD for 14 consecutive days

Dietary Supplement: Probiotic 2

Placebo

PLACEBO COMPARATOR

Acidified dairy drink without ferments consumed as follows: one bottle (100g) OD for 14 consecutive days

Dietary Supplement: Placebo

Interventions

Probiotic 1 DIETARY_SUPPLEMENT

Fresh fermented dairy drink containing yoghurt ferments

Probiotic 1

Probiotic 2 DIETARY_SUPPLEMENT

Fresh fermented dairy drink containing probiotic strain

Probiotic 2

Placebo DIETARY_SUPPLEMENT

Acidified dairy drink without ferments

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• Zaccaria E, Klaassen T, Alleleyn AME, Boekhorst J, Smokvina T, Kleerebezem M, Troost FJ. Endogenous small intestinal microbiome determinants of transient colonisation efficiency by bacteria from fermented dairy products: a randomised controlled trial. Microbiome. 2023 Mar 7;11(1):43. doi: 10.1186/s40168-023-01491-4.

  PMID: 36879297 DERIVED

Study Officials

• Fred Troost, PhD

  Maastricht University Medical Center (MUMC+)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: November 11, 2017
• Study Completion: November 11, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)