Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children

• ClinicalTrials.gov Identifier: NCT02786160
• Recruitment Status: Completed
• First Posted: May 30, 2016
• Last Update Posted: December 13, 2018
• Sponsor: Glycom A/S
• Information provided by (Responsible Party): Glycom A/S

Tracking Information

• First Submitted Date: May 23, 2016
• First Posted Date: May 30, 2016
• Last Update Posted Date: December 13, 2018
• Study Start Date: May 2016
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 25, 2016): Change from baseline in faecal microbiota profile [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 25, 2016)

• Change from baseline in clinical chemistry [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline in haematology [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline in gastrointestinal symptoms measured via the gastrointestinal symptom rating scale (GSRS) [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline in Bristol Stool Form Scale (BSFS) [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline in specific host-bacteria metabolic biomarkers in blood [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline of HOMA-IR [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline of BMI-SDS [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline of fat percentage [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline of waist circumference [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline of hip circumference [ Time Frame: Baseline and after 4 and 8 weeks of intake, and after 2 and 10 months of wash-out ]
• Change from baseline of specific blood biomarkers related to gut barrier function [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline of specific blood biomarkers related to inflammation [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]
• Change from baseline of specific faecal biomarkers related to inflammation [ Time Frame: Baseline and after 8 weeks of intake, and after 10 months of wash-out ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children
• Official Title: The Effects of Human Milk Oligosaccharides (HMO) on the Faecal Microbiota and on Host Metabolism in Obese Children: A Parallel, Double-blind, Randomized, Placebo-controlled Study

Brief Summary

The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Obesity

Intervention

• Dietary Supplement: HMO
• Dietary Supplement: Dextropur

Study Arms

• Active Comparator: HMO1
  Daily bolus of HMO1
  Intervention: Dietary Supplement: HMO
• Active Comparator: HMO2
  Daily bolus of HMO2
  Intervention: Dietary Supplement: HMO
• Placebo Comparator: Dextropur
  Daily bolus of Dextropur
  Intervention: Dietary Supplement: Dextropur

• Publications *: Fonvig CE, Amundsen ID, Vigsnaes LK, Sorensen N, Frithioff-Bojsoe C, Christiansen M, Hedley PL, Holm LA, McConnell B, Holm JC. Human Milk Oligosaccharides Modulate Fecal Microbiota and Are Safe for Use in Children With Overweight: A Randomized Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Sep 1;73(3):408-414. doi: 10.1097/MPG.0000000000003205.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 25, 2016): 75
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2018
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Informed, written consent by the child's representative(s) and informed verbal assent by the child
2. Age ≥5 and <11 years at visit 0
3. BMI SDS of ≥ 2.3
4. Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
5. Ability and willingness to understand and comply with the study procedures
6. The child's representative(s) need(s) to read, speak and understand Danish

Exclusion Criteria:

1. Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
2. Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
3. Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
4. Psychiatric disease, as judged by the investigator.
5. Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
6. Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
8. Lack of suitability for participation in the study for any reason as judged by the investigator.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02786160
• Other Study ID Numbers: NATROB; SJ-528 ( Other Identifier: Den Videnskabsetiske Komité for Region Sjaelland )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Glycom A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: Glycom A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jens-Christian Holm, MD, PhD; Holbaek Hospital

• PRS Account: Glycom A/S
• Verification Date: December 2018