Irritable Bowel Syndrome-like SymptomsRelieveNCT06104631
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
A study testing BK003 in people with Irritable Bowel Syndrome-like Symptoms and Crohn Disease Remission, run by Biokuris s.a. at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome-like Symptoms, Crohn Disease Remission
- What is being tested?
- BK003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Mar 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged from 18 years to 75 years,
- Long standing (>3 months prior to V1) steroid-free clinical remission Crohn's disease according to clinical and biochemical assessments,
- Clinical remission (according to the investigator),
- Absence of inflammatory markers at V1,
- Presence of IBS-like symptoms according to Rome IV criteria,
- Likert scale ≥ 3 for abdominal pain at V0,
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- Patient with correct and complete reporting of the study questionnaires and scores during the run-in period (≥ 75% completion),
- To continue all medication used in the last month before inclusion at the same dosage,
- Anti-spasmodic, hypomotility agents, probiotics, prebiotics, bile-acid chelators, and anti-depressants are authorized if consumed for longer than 1 month before inclusion and maintained at a stable dosage for the entire study duration,
- Agreeing to maintain their lifestyle behaviours during the participation in the study,
- Patient has read, understood, and signed the informed consent form (ICF),
- Patients capable of communicating with the investigator, replying to the questionnaires, and understanding the requirements and constraints of the study protocol,
- Possession of a digital device (i.e., smartphone or tablet),
- Patient willing to adhere to the study visit schedule and able to understand and comply with protocol requirements and product administration,
- Male or female patient of childbearing potential who agrees to use acceptable methods of birth control (oral, transdermal, systemic contraception, intrauterine device, condom) for the duration of the study,
- Patient can read and write in French.
Who cannot join
- Patients with other concomitant organic gastrointestinal abnormalities besides Crohn's disease: ano-perineal lesions, extra-intestinal manifestations of Crohn's disease, colorectal history of cancer or abdominal radiotherapy, symptomatic intestinal stenosis, substance dependence history,
- Patients with significant comorbidities: instable cardiovascular diseases, complicated diabetes, instable thyroid function,
- Patients receiving non-steroidal anti-inflammatory drugs, steroids, opioids, or narcotic analgesics in the last month before V0,
- Patients beginning a diet or a specific treatment for functional symptoms (probiotics, prebiotics, anti spasmodic, chelators, anti-depressants, etc.) within one month before V1,
- Ongoing antibiotics or antibiotics prescribed in the last 2 weeks before V1.
- Excessive alcohol consumption (>30 g/day [i.e., 3 units/day] for men and >20 g/day [i.e., 2 units/day] for women) and/or drug abuse,
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- Pregnancy and lactation, or plan to become pregnant during the study period,
- Participation in other studies involving investigational or marketed products concomitantly or less than 3 months prior to V0,
- Known hypersensitivity to any of the ingredients or excipients of the study products,
- Patient who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
CHU Liege - Gastroenterology
Liège, 4000
About this study
Official title: A 10-week Randomized Double-blinded Crossover Trial of BiOkuris® Chitin-glucan Based Formulation Versus Placebo in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
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.
Read more
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.
- Being tested
- BK003, Placebo
- Keywords
- chitin-glucan, Crohn, IBS, Irritable Bowel Syndrome-like
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BK003Other
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.
PlaceboOther
The placebo product has the same composition in excipient, same form and same posology as BK003.
| Study group | Role | What they receive |
|---|---|---|
| BK003 | Experimental | Dietary Supplement: BK003 The product is a combination of chitin-glucan and micronutrients. The dose of chitin-glucan is 3 g/day. The product is provided as sachets containing powder to be dissolved in a glass of water (about 250 ml) and taken orally. Receives: Other: BK003 |
| Placebo | Placebo comparator | Dietary Supplement: BK003 placebo The placebo product has the same composition in excipient, same form and same posology as BK003. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject'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.
Measured: at week 4 after randomization on period I (cross over) and at week 4 after wash-out period II (cross over)
Secondary outcomes (7)
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: At week 0, week 4, week 6, week 10 post-run in period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start12 Mar 2024
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome-like SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomised, double-blind, placebo controlled, multicentre, crossover study of BK003 in adult patients with Crohn's disease in remission without treatment or with stable maintenance therapy and having IBS-like symptoms. Patients will be recruited in the university hospitals of Liège (Belgium) and Lille (France). The recruitment period will last 1 year. This study will consist of a 2 to 3-week run-in period. Then, patients will take either placebo or BK003 for 4 weeks, stop for 2 to 3 weeks (washout) and then switch products for 4 additional weeks. Patients will undergo 5 visits: V0 (screening visit), V1 (randomization visit, 2 to 3 weeks ± 4 days after V0), V2 (washout, 4 weeks ± 4 days after V1), V3 (crossover, 18 days ± 3 days after V2) and V4 (end of study visit, 4 weeks ± 4 days after V3).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biokuris s.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104631
- Sponsor's protocol ID
- BK-IBSLike-2302
- Acronym
- Relieve
- Status last verified
- Feb 2025
- First submitted
- 17 Oct 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10-week Randomized Double-blinded Crossover Trial of BiOkuris® Chitin-glucan Based Formulation Versus Placebo in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like Symptoms
- ClinicalTrials.gov ID
- NCT06104631
- Acronym / sponsor ID
- Relieve / BK-IBSLike-2302
- Keywords
- chitin-glucan, Crohn, IBS, Irritable Bowel Syndrome-like
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biokuris s.a.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomised, double-blind, placebo controlled, multicentre, crossover study of BK003 in adult patients with Crohn's disease in remission without treatment or with stable maintenance therapy and having IBS-like symptoms. Patients will be recruited in the university hospitals of Liège (Belgium) and Lille (France). The recruitment period will last 1 year. This study will consist of a 2 to 3-week run-in period. Then, patients will take either placebo or BK003 for 4 weeks, stop for 2 to 3 weeks (washout) and then switch products for 4 additional weeks. Patients will undergo 5 visits: V0 (screening visit), V1 (randomization visit, 2 to 3 weeks ± 4 days after V0), V2 (washout, 4 weeks ± 4 days after V1), V3 (crossover, 18 days ± 3 days after V2) and V4 (end of study visit, 4 weeks ± 4 days after V3).
| Arm | Type | Receives |
|---|---|---|
| BK003 | Experimental | Other: BK003Dietary Supplement: BK003 The product is a combination of chitin-glucan and micronutrients. The dose of chitin-glucan is 3 g/day. The product is provided as sachets containing powder to be dissolved in a glass of water (about 250 ml) and taken orally. |
| Placebo | Placebo comparator | Other: PlaceboDietary Supplement: BK003 placebo The placebo product has the same composition in excipient, same form and same posology as BK003. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female patients aged from 18 years to 75 years,
- Long standing (>3 months prior to V1) steroid-free clinical remission Crohn's disease according to clinical and biochemical assessments,
- Clinical remission (according to the investigator),
- Absence of inflammatory markers at V1,
- Presence of IBS-like symptoms according to Rome IV criteria,
Key exclusion criteria (10 listed)
- Patients with other concomitant organic gastrointestinal abnormalities besides Crohn's disease: ano-perineal lesions, extra-intestinal manifestations of Crohn's disease, colorectal history of cancer or abdominal radiotherapy, symptomatic intestinal stenosis, substance dependence history,
- Patients with significant comorbidities: instable cardiovascular diseases, complicated diabetes, instable thyroid function,
- Patients receiving non-steroidal anti-inflammatory drugs, steroids, opioids, or narcotic analgesics in the last month before V0,
- Patients beginning a diet or a specific treatment for functional symptoms (probiotics, prebiotics, anti spasmodic, chelators, anti-depressants, etc.) within one month before V1,
- Ongoing antibiotics or antibiotics prescribed in the last 2 weeks before V1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BK003The 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. | Other | BK003 |
| PlaceboThe placebo product has the same composition in excipient, same form and same posology as BK003. | Other | Placebo |
Primary outcome
Subject's global assessment (SGA)
Time frame: at week 4 after randomization on period I (cross over) and at week 4 after wash-out period II (cross over)
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.
7 secondary outcomes
Individual symptoms
Time frame: weekly from randomization up to the end of the study (week 10 post run in)
Stool consistency & dyschesia
Time frame: weekly from randomization up to the end of the study (week 10 post run in)
Stool number
Time frame: weekly from randomization up to the end of the study (week 10 post run in period)
IBS-related quality of life
Time frame: At week 0, week 4, week 6, week 10 post-run in period
Anxiety and depression
Time frame: At week 0, week 4, week 6, week 10 post-run in period
Serum CRp & fecal calprotectine
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
Time frame: At week 0, week 4, week 6, week 10 post-run in period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BK003 in people with Irritable Bowel Syndrome-like Symptoms and Crohn Disease Remission, run by Biokuris s.a. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salvatore Modica (+32 4 259 85 00, s.modica@biokuris.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's global assessment (SGA) (time frame: at week 4 after randomization on period I (cross over) and at week 4 after wash-out period II (cross over)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.