To assess the effects of a Human Milk Oligosaccharide mix given once daily for 12 weeks on stool consistency and abdominal pain compared to placebo in individuals with Irritable Bowel Syndrome (IBS).
HMO mix has been shown to provide therapeutic benefits to individuals with IBS of all subtypes (Palsson et al., 2019). DSM is planning this trial in order to investigate if clinically relevant improvements in bowel movements and IBS symptoms can be obtained through the use of the HMO mix in individuals with moderate to severe IBS and abdominal pain. Eligible participants will have a diagnosis of Irritable Bowel Syndrome (IBS). Participants will be assessed for eligibility at the screening visit, must meet all the inclusion criteria, and none of the exclusion criteria. In this trial, participants will be randomized to one of two intervention groups (a Human Milk Oligosaccharide mix or placebo) and receive intervention for at least 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
204
Subjects takes 5.5 g of powder mixed in water once a day for 12 weeks.
The placebo to be used in this trial is 5.5 g of powdered dextrose powder in a single-serve stick pack. The participants will be instructed to mix the product in a 4-6 oz glass of water and consume in the morning once a day for 12 weeks.
Atlantia Clinical Trials Ltd
Cork, Cork/Munster, Ireland
Absolute change in the proportion of stools with abnormal fecal consistency in the active product compared to placebo group.
Participants will identify each bowel movement 'type' using the Bristol Stool Scale (Type 1 = hard stool difficult to pass \[classified as severe constipation\]; Type 7 = watery, entirely liquid stool \[classified as severe diarrhea\]). Types 1 and 2 would be considered to suggest severe and mild diarrhea, respectively. Types 6 and 7 would be considered to suggest mild and severe diarrhea, respectively. This endpoint will compare the proportion of participants experiencing constipation and diarrhea between the groups
Time frame: Baseline (2 week run in period) to end of intervention (weeks 11 + week 12)
Absolute change in the pain severity score (IBS-SSS) in the active product compared to placebo group.
The IBS Symptom Severity Scale (IBS-SSS) contains a pain subscale which asks participants to rate abdominal pain the past 10 days on a scale from 0 to 100, with 0 meaning "no pain" and 100 meaning "very severe pain". The minimum score is 0 and the maximum achievable score is 100.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Absolute change in total IBS severity score in the active product compared to placebo group.
The IBS Symptom Severity Scale (IBS-SSS) contains 5 items. Each of the five questions generate a maximum score of 100 using prompted visual analogue scales. The minimum score is 0 and the maximum achievable score is 500.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Absolute change in total IBS Quality of Life (IBS-QOL) score in the active product compared to placebo group.
The IBS Quality of Life contains 34 items each with a five-point response scale, where 1 represents not at all and 5 extremely/A great detail. The participant ill answer each question with respect to the impact of IBS and it's treatment. The individual responses to the 34 items are summed and averaged for a total score and transformed to a 0-100 scale for interpretation with higher scores indicating better IBS specific quality of life.
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Time frame: Baseline (Visit 2) to Week 12 (Visit 3)
Relative change in abundance of fecal Bifidobacteria spp in the active product compared to placebo group.
Relative change in abundance measured by gene sequencing analysis of fecal sample.
Time frame: Baseline (Visit 2) to Week 12 (Visit 3)