Crohn's disease is a chronic and complex inflammatory bowel disease affecting the gastrointestinal tract, causing symptoms like abdominal pain, diarrhea, and fatigue. While its exact cause is unclear, it involves genetic, environmental, and immunological factors. Crohn's disease can lead to nutrient deficiencies and has unpredictable flare-ups and remission periods. During the remission phases, irritable bowel syndrome (IBS)-like symptoms can persist in 50% of patients, for which no satisfactory treatment is available yet. Chitin-glucan is prebiotic, obtained by extraction, isolation and purification from a fungal resource: the mycelium of Aspergillus niger (a microscopic fungus of the Ascomycetes family) of which it composes the cell walls. The biopolymer consists essentially of two types of polysaccharide chains: chitin (poly-N-acetyl-D-glucosamine) and beta-(1,3)-D-glucan (D-glucose units linked essentially via beta-1,3 bonds). Because of its beta bond, human intestinal enzymes cannot digest it, as a result, the majority of chitin-glucan can reach the colon where it can be fermented by the microbiota. By modulating the composition and/or activity of the intestinal microbiota, fermentation of chitin-glucan could have beneficial effects on health. The aim of the RELIEVE study is to assess if BK003 could improve the relief of global symptoms, individual symptoms, stool consistency and frequency of evacuations, quality of life, anxiety, and depression in patients with Crohn's disease in remission without treatment or with stable maintenance therapy and having IBS-like symptoms and to confirm the product's safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
50
The product is a combination of chitin-glucan and other dietary complement components. The dosage of chitin-glucan is 3 g/day. The product is a powder for oral administration 1x/day.
The placebo product has the same composition in excipient, same form and same posology as BK003.
CHU Liege - Gastroenterology
Liège, Belgium
RECRUITINGCHU Lille - Gastroenterology
Lille, France
RECRUITINGSubject's global assessment (SGA)
Subjective global assessment of relief responder rate. SGA is scored on a 5-point Likert scale (1 = completely relieve and 5= being worse). Patients with an SGA of relief score from 1 to 3 is considered as responder.
Time frame: at week 4 after randomization on period I (cross over) and at week 4 after wash-out period II (cross over)
Individual symptoms
Weekly change from baseline in mean 7-point Likert scale for each of the symptoms: abdominal pain, abdominal bloating, flatulence. Scores of each symptoms will be assessed (from 1= none to 7= very severe) every day and mean scores of each symptoms will be calculated every week of the treatment period I \& II and compared with baseline (run-in period).
Time frame: weekly from randomization up to the end of the study (week 10 post run in)
Stool consistency & dyschesia
Weekly change from baseline on number of normal stool. BSS score, including dyschesia, will be assessed every day and mean scores will be calculated every week until the end of the study
Time frame: weekly from randomization up to the end of the study (week 10 post run in)
Stool number
Weekly change from baseline on number of evacuations per day. The mean daily number of bowel movements will be calculated for each week until the end of the study
Time frame: weekly from randomization up to the end of the study (week 10 post run in period)
IBS-related quality of life
The absolute and relative change of IBS-related quality of life score.
Time frame: At week 0, week 4, week 6, week 10 post-run in period
Anxiety and depression
The absolute and relative change of anxiety and depression (HADS score)
Time frame: At week 0, week 4, week 6, week 10 post-run in period
Serum CRp & fecal calprotectine
Change from baseline for the following measures : serum CRP, fecal calprotectine, alpha diversity and the relative abundance of bacterial, viral and fungal taxa in stools
Time frame: at week 4 versus week 0 (period I) and at week 10 versus week 6 (period II) post run in period
Adverse events
Occurence and severity of adverse events
Time frame: At week 0, week 4, week 6, week 10 post-run in period
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