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

Phase 2

Completed

• Conditions: colectomy; ileostomy; 10017943

• Registration Number: NL-OMON45768
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-27
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

- Ileostomy installed at least 2 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:
- Test days at university facility
- Being able to collect ileal effluent samples at regular basis over the required period of time
- Compliant to dietary restrictions and reliable for sample collection
- Subject who regularly consumes dairy fermented products containing live bacteria
- 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.)
- Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective and having given written (dated and signed) informed consent form to take part in the study

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.
- Abnormal/artificial heart valves, history of rheumatic heart disease or of infectious endocarditis, cardiac malformation
- 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
- Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks, or who plans to have one during the course of the study
- Subject that have had dental surgery in the last 4 weeks or plan to have dental surgery during the course of the study, excluding care of tooth decay
- 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
- Self-admitted HIV-positive status
- Use of medication, including proton pump inhibitors, non-steroidal anti-inflammatory drugs interfering with endpoints (to be determined by the principal investigator and the medically responsible MD; but except oral contraceptives), within 14 days prior to and during participation.
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine interfering with endpoints (to be determined by the principal investigator and the medically responsible MD), 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
- Known pregnancy (assessed by a pregnancy test before start of study), lactation
- Abuse of products: alcohol (> 20 alcohol units per week) and drugs
- Blood donation within 3 months before study period
- History of any side effects towards intake of pro- or prebiotic supplements of any kind.
- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* To assess the effects of consumption of milk fermented by Lactobacillus<br /><br>rhamnosus CNCM I-3690 and of milk fermented by a yogurt symbiosis of<br /><br>Streptococcus thermophilus CNCM I-1630 and Lactobacillus bulgaricus CNCM I-1519<br /><br>for 2 weeks on temporal microbial composition and activity in the small<br /><br>intestine. </p><br>