Modulation of Microbial Composition in Ileostomy Patients (INSIDE)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Dietary Supplement: Probiotic 1; Dietary Supplement: Placebo; Dietary Supplement: Probiotic 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02920294

METC 163023

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

Probiotic 1

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic 1

Probiotic 2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic 2

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo