Modulation of Microbial Composition in Ileostomy Patients

NCT ID: NCT02920294

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-11-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic 1

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

Group Type: ACTIVE_COMPARATOR

Probiotic 1

Intervention Type: DIETARY_SUPPLEMENT

Fresh fermented dairy drink containing yoghurt ferments

Probiotic 2

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

Group Type: ACTIVE_COMPARATOR

Probiotic 2

Intervention Type: DIETARY_SUPPLEMENT

Fresh fermented dairy drink containing probiotic strain

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Acidified dairy drink without ferments

Interventions

Probiotic 1

Fresh fermented dairy drink containing yoghurt ferments

Intervention Type: DIETARY_SUPPLEMENT

Probiotic 2

Fresh fermented dairy drink containing probiotic strain

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Acidified dairy drink without ferments

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fred Troost, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center (MUMC+)

Locations

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 36879297 (View on PubMed)

Other Identifiers

METC 163023

Identifier Type: -

Identifier Source: org_study_id