Irritable Bowel Syndrome (IBS) Clinical Trial
— GRIPSOfficial title:
Real-World Perception of Tolerability and Bowel Function Effects of Fuco-N-Tetraose in IBS Patients
Verified date | April 2019 |
Source | Glycom A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 317 |
Est. completion date | March 20, 2019 |
Est. primary completion date | March 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Glycom, Inc. | University of North Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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