Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2018 |
| Start Date: | May 14, 2018 |
| End Date: | March 2019 |
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.
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.
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.
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.
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