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Trial record 1 of 1 for:    NCT02875847
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Effects of HMOs on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in IBS Patients

This study is currently recruiting participants.
Verified June 2017 by Glycom A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT02875847
First Posted: August 23, 2016
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Glycom A/S
  Purpose

The study is a randomised, placebo-controlled, double-blind parallel study in IBS patients. A total of 60 adult patients diagnosed with IBS-C, -D or -A/M according to Rome IV criteria will be included. The participants will be randomized into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effect of HMOs on the faecal microbiota in IBS patients. Secondary objectives are to assess the effect on gastrointestinal symptoms, mucosal immunity, gut barrier function, quality of life, and anxiety and depression.


Condition Intervention Phase
Irritable Bowel Syndrome (IBS) Dietary Supplement: HMO1 Dietary Supplement: HMO2 Dietary Supplement: Dextropur Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Human Milk Oligosaccharides on Faecal Microbiota, Gastrointestinal Symptoms, Mucosal Immunity and Barrier Function in Irritable Bowel Syndrome: a Parellell, Double-blind, Randomised, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Glycom A/S:

Primary Outcome Measures:
  • Change from baseline in intestinal bifidobacteria abundance [ Time Frame: Baseline and after 4 weeks of intake ]

Secondary Outcome Measures:
  • Change from baseline of faecal microbiota profile [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of IBS symptoms as measured via the total score on the IBS Symptoms Severity Scale (IBS-SSS) and the proportion of responders in all patients and subgroup of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of intensity of abdominal pain and number of days of abdominal pain as measured on the 11 point Numeric Rating Scale (NRS-11) in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of bowel habits as measured via the IBS-SSS, the Bristol Stool Form Scale (BSFS) and a bowel movement diary in all patients and subgroup of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of abdominal distention as measured via the IBS-SSS in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale for IBS patients (GSRS-IBS) in all patients and subgroup of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of quality of life in IBS patients as measured by the IBS-QOL in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of anxiety and depression as measured by the Hospital Anxiety and Depression Scales (HADS) in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of gastrointestinal symptom specific anxiety as measured by the Visceral Sensitivity Index (VSI) in all patients and subgroup of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of severity of somatic symptoms as measured by the Patient Health Questionnaire-15 (PHQ-15) in all patients and subgroup of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of biomarkers of inflammation in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of biomarkers of gut barrier function in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]
  • Change from baseline of biomarkers of the gut-brain axis in all patients and subgroups of patients [ Time Frame: Baseline and after 4 weeks of intake, and after 4 weeks of wash-out ]

Estimated Enrollment: 60
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HMO1
Daily bolus of HMO1
Dietary Supplement: HMO1
Active Comparator: HMO2
Daily bolus of HMO2
Dietary Supplement: HMO2
Placebo Comparator: Dextropur
Daily bolus of dextropur
Dietary Supplement: Dextropur

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed written informed consent
  2. Age between 18 and 60 years at visit 2
  3. Fulfills definition of IBS-D, IBS-C or IBS-A/M according to Rome IV criteria
  4. Have a global IBS-SSS score of >174 during the 2 weeks run-in period
  5. Read, speak and understand Swedish
  6. Ability and willingness to understand and comply with the study procedures

Exclusion Criteria:

  1. Participation in a clinical intervention trial one month prior to screening visit and throughout the study.
  2. Any known gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator; in particular

    • lactose intolerance
    • coeliac disease
  3. Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
  4. Severe psychiatric disease and/or psychological disturbance, as judged by the investigator.
  5. Use of highly dosed probiotic supplements (yoghurt allowed) one month prior to the study and throughout the study. Excluded products are (i) probiotic supplements in the form of capsules, tablets, and powders in sachets, and (ii) probiotic food and drink products which contain high doses of probiotics. The excluded food and drink products are available in the form of yoghurts, drinking yoghurts, shots and drinks under brands such as Proviva, Actimel, Activia, Wellness, and Verum.
  6. Consumption of antibiotic drugs one month prior to screening and throughout the study. Antibiotic use within the last three months prior to screening will be registered.
  7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) two weeks prior to screening and throughout the study. Specifically excluded drugs are opioids, NSAIDs on a weekly basis, regular use of laxatives and anti-diarrhoeal drugs, any drugs indicated for IBS symptoms.
  8. Diagnosed with and treated for IBS for more than 10 years
  9. Pregnant or lactating or wish to become pregnant during the period of the study.
  10. Lack of suitability for participation in the study for any reason as judged by the investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875847


Contacts
Contact: Emma Elison, PhD ct@glycom.com
Contact: Magnus Simrén, MD, PhD magnus.simren@medicine.gu.se

Locations
Sweden
SU Sahlgrenska, Department of Internal Medicine Recruiting
Göteborg, Sweden, SE-413 35
Contact: Magnus Simrén, MD, PhD       magnus.simren@medicine.gu.se   
Contact: Hans Törnblom, MD, PhD       hans.tornblom@gu.se   
Sponsors and Collaborators
Glycom A/S
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: Magnus Simrén, MD, PhD Department of Internal Medicine
Principal Investigator: Hans Törnblom, MD, PhD Department of Internal Medicine
Principal Investigator: Lena Öhman, PhD Department of Internal Medicine
  More Information

Responsible Party: Glycom A/S
ClinicalTrials.gov Identifier: NCT02875847     History of Changes
Other Study ID Numbers: NATRIBS
Dnr: 548-16 ( Other Identifier: Regionala Etikprövningsnämnden i Göteborg )
First Submitted: August 12, 2016
First Posted: August 23, 2016
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases