Clinical trial NCT03550742: Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients
Official title: Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Human Milk Oligosaccharides
IBS-C
IBS-D
IBS-M
Lead sponsor: Glycom A/S
Sponsor class: INDUSTRY
Collaborators: name: University of North Carolina
First posted: 2018-06-08
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks.

The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.

Detailed description: In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.

The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.

Eligibility criteria: Inclusion Criteria:

1. Ability to give oral and written informed consent
2. Age minimum 18 years at enrolment
3. Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
4. Ability and willingness to understand and comply with the study procedures
5. Ability to read, speak and understand English
6. Free access to the internet via computer, tablet or smartphone to complete study surveys and also to allow for study team follow-up as needed.

Exclusion Criteria:

1. Participation in a clinical intervention study one month prior to screening visit and throughout the study.
2. Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
3. Pregnant or lactating or wish to become pregnant during the period of the study.
4. Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.

Primary outcomes:
measure: Change from baseline in bowel function
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
Secondary outcomes:
measure: Change in patients' perception of body function
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Evaluate tolerability of fuco-N-tetraose
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Evaluate tolerability of fuco-N-tetraose
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Change in satisfaction with bowel habits
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Change in IBS' interference in life in general
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Change in quality of life
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Change on somatic symptoms
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
measure: Change in anxiety and depression
timeFrame: Baseline and after 4, 8 and 12 weeks of intake
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill School of Medicine
name: Olafur Palsson, PsyD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palsson OS, Peery A, Seitzberg D, Amundsen ID, McConnell B, Simren M. Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00276. doi: 10.14309/ctg.0000000000000276.