Irritable Bowel Syndrome (IBS) Clinical Trial
Official title:
Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
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.
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.
;
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