Clinical trial NCT02920294: Modulation of Microbial Composition in Ileostomy Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: probiotics, microbiota, ileostoma
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Temporal microbial composition and activity in the small intestine in ileal effluent
timeFrame: 2 weeks intervention
Secondary outcomes:
measure: Small intestinal permeability by a multi sugar test (urinary recovery of test sugars)
timeFrame: 2 weeks intervention
measure: Gene transcription response in blood by transcriptome patterns.
timeFrame: 2 weeks intervention
measure: The levels of a panel of peripheral blood biomarkers related to immune, metabolic and hormonal status
timeFrame: 2 weeks intervention
measure: The level of whole blood immune responsiveness to a panel of standardized stimuli ex vivo
timeFrame: 2 weeks intervention
measure: Morning urine metabolome profiles
timeFrame: 2 weeks intervention
measure: Peripheral blood metabolome profiles
timeFrame: 2 weeks intervention
measure: The relative survival of bacterial strains (colony forming unit enumeration on semi-selective culture plates)
timeFrame: 2 weeks intervention
measure: Short chain fatty acid profiles in ileal effluent
timeFrame: 2 weeks intervention
measure: Number of participants with Gastrointestinal symptoms by Visual Analogue Scales
timeFrame: 2 weeks intervention
measure: Occurrence and severity of treatment related adverse events
timeFrame: 2 weeks intervention
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center (MUMC+)
name: Fred Troost, PhD
role: PRINCIPAL_INVESTIGATOR
References: