Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients

Conditions
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Irritable Bowel Syndrome (IBS)

Intervention / Treatment
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* Other: Fuco-N-Tetraose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to give oral and written informed consent Age minimum 18 years at enrolment Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria Ability and willingness to understand and comply with the study procedures Ability to read, speak and understand English 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: Participation in a clinical intervention study one month prior to screening visit and throughout the study. Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor Pregnant or lactating or wish to become pregnant during the period of the study. Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks. | Other: Fuco-N-Tetraose<br>* Daily bolus of Fuco-N-Tetraose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in bowel function | Change from baseline in bowel function assessed as the proportion of bowel movements with abnormal fecal consistency measured with the Bristol Stool Form Scale | Baseline and after 4, 8 and 12 weeks of intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patients' perception of body function | Change from baseline in patients' perception of body function measured by the Patients' Global Impression of Change (PGIC) scale. | Baseline and after 4, 8 and 12 weeks of intake | 
| Evaluate tolerability of fuco-N-tetraose | Evaluate tolerability of fuco-N-tetraose using GSRS-IBS | Baseline and after 4, 8 and 12 weeks of intake | 
| Evaluate tolerability of fuco-N-tetraose | Evaluate tolerability of fuco-N-tetraose using IBS-SSS | Baseline and after 4, 8 and 12 weeks of intake | 
| Change in satisfaction with bowel habits | Change from baseline in satisfaction with bowel habits measured with IBS-SSS | Baseline and after 4, 8 and 12 weeks of intake | 
| Change in IBS' interference in life in general | Change from baseline in IBS' interference in life in general measured with IBS-SSS | Baseline and after 4, 8 and 12 weeks of intake | 
| Change in quality of life | Change from baseline in quality of life measured with the IBS Quality of Life Scale (IBS-QoL) | Baseline and after 4, 8 and 12 weeks of intake | 
| Change on somatic symptoms | Change from baseline on somatic symptoms measured with the Participant Health Questionnaire-12 (PHQ-12) | Baseline and after 4, 8 and 12 weeks of intake | 
| Change in anxiety and depression | Change from baseline in anxiety and depression measured with the Participant Health Questionnaire-4 (PHQ-4) | Baseline and after 4, 8 and 12 weeks of intake | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Milk Oligosaccharides, IBS-C, IBS-D, IBS-M