Irritable Bowel SyndromeNCT05348642
Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to IBS
A study testing pasteurized A. muciniphila in people with Irritable Bowel Syndrome, run by A-Mansia Biotech S.A. at 1 site in Germany.
Trial summary
Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- pasteurized A. muciniphila
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 21 Jul 2022to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women from 18 to 70 years old
- Meeting Rome-IV criteria for IBS:
- Recurrent abdominal pain on average ≥1 day/ week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
- Related to defecation
- Associated with a change in frequency of stool
- Associated with a change in form (appearance) of stool
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- Consistent and stable body weight in the last 3 months prior to study (less than 5% self-reported change)
- Having access to a smartphone or a computer with an internet access, either allowing a video call, and familiar with the use thereof (checked during the visit)
- Subject's agreement to comply with study procedures, in particular:
- to take IP as recommended
- to avoid the use of other products which may influence the GI complaints during the study
- to keep the habitual dietary habits, type and level of physical activity (including any specific exercise such as e.g. yoga) as well as the level of caffeine or nicotine (if any)
- to complete the subject diary and study questionnaires
- Women of childbearing potential:
- commitment to use contraception methods
- negative pregnancy testing (beta human chorionic gonadotropin test in urine)
- Readiness not to participate in another clinical study during this study
Who cannot join
- Self-reported known allergy or hypersensitivity to any of the components of the investigational product
- Self-reported nocturnal GI complaints
- Women of childbearing potential: self-reported GI complaints mainly related to menstruation
- Self-reported lactose or fructose intolerance
- Self-reported acute or chronic significant GI disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis, disorders in digestive tract motility etc.)
- Self-reported local anorectal problems (e.g. anal fissure, bleeding haemorrhoids)
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- Self-reported clinically significant findings in colonoscopy within the 2 years prior to study
- Family history (immediate family) of colorectal cancer or inflammatory bowel disease; anxiety or depression requiring medication
- Acute or chronic psychiatric disease (e.g. depression, anxiety, bipolar disorder) requiring medication
- History and/or presence of other clinically significant condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.:
- unstable thyroid gland disorder
- unstable hypertension
- unstable diabetes mellitus
- eating disorder
- immunodeficiency
- relevant gynecological or urological disorder
- any other relevant serious organ or systemic diseases (e.g. cardiovascular, liver, renal disease etc.)
- Significant GI surgery within the last 6 months prior to or planned during the study
- Regular medication and/or supplementation within the last month prior to and during the study:
- antibiotics, probiotics, metformin
- for management of IBS complaints, such as bile acid binders (e.g. cholestyramine), rifaximin, alosetron, lubiprostone, eluxadoline, linaclotide, peppermint oil
- that could influence gastrointestinal functions (e.g. laxatives, opioids, systemic corticosteroids, anticho-linergics, anti-diarrheals etc.) as per investigator judgement
- Regular use of psychotropic drugs (e.g. hypnotics / sedative drugs, anxiolytics, antidepressants, neuroleptics, anticonvulsants) within 3 months prior to study or adaptogens (e.g. ginseng, St. John's Wort) within 6 weeks prior to and during the study
- Introductions of a specific diet (e.g. low carb, vegan, high-fibre, low FODMAP within last 3 months prior to and during the study
- Women of child-bearing potential: pregnancy or nursing
- History of or current abuse of drugs, alcohol or medication
- Participation in another study during the last 30 days prior to and during the study
- Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to Irritable Bowel Syndrome
Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome.
Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability.
Read the detailed description
Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction, globally affecting about 10% of the population. Typical predominant traits are abdominal pain and abnormal bowel habits. The use of probiotics in IBS has been continuously assessed; in recent systematic reviews and meta-analyses, single or combined probiotic strains were indicated to have beneficial effects and good tolerability in the affected population.
pAkk has recently been assessed as a safe novel food ingredient. Beneficial effects and very good tolerability of pAkk have been reported in individuals with metabolic disorders. The objective of the present clinical study - a double-blind, randomised, placebo-controlled, parallel group design, explorative pilot 12-week nutritional study, is to assess the potential of pAkk in IBS management.
The main study objective is then to evaluate the benefit of pAkk in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability. In total, 90 participants will be enrolled and will attend 4 study visits: one on site and 3 televisits.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- pasteurized A. muciniphila, placebo
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pasteurized A. muciniphilaDietary supplement
pasteurized A. muciniphila - oral daily dose
placeboDietary supplement
Placebo = identical to verum regarding the form, size, taste, color and intake
| Study group | Role | What they receive |
|---|---|---|
| Experimental group receiving pasteurized Akkermansia muciniphila | Experimental | pasteurized Akkermansia muciniphila - daily oral dose Receives: Dietary Supplement: pasteurized A. muciniphila |
| Control group | Placebo comparator | Control group receiving placebo, identical to verum regarding the form, size, taste, color and intake. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Severity Scoring System / IBS-SSS
Changes at each timepoint of assessment in comparison to baseline. IBS-SSS is between 0 and 500, with a higher score meaning more severe symptoms.
Measured: From baseline to day 14, day 42 and day 84
Secondary outcomes (6)
Irritable Bowel Syndrome-Global Improvement Scale / IBS-GIS
Changes at each timepoint of assessment in comparison to baseline. The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "How would you rate your IBS signs or symptoms over the past 7 days": Subjects respond on a scale of 1-7 where: 1 = Significantly relieved, 2 = Moderately relieved, 3 = Slightly relieved, 4 = Unchanged, 5 = Slightly worse, 6 = Moderately worse, 7 = Significantly worse.
Measured: From baseline to day 14, day 42 and day 84
3-day diary data on stool frequency
Changes at each timepoint of assessment in comparison to baseline
Measured: From baseline to day 84
3-day diary data on stool consistency (Bristol Stool Form Scale / BSFS)
Changes at each timepoint of assessment in comparison to baseline. The Bristol Stool Form Scale is a 7 score visual scale to measure stool consistency. (1) Separate hard lumps like nuts (difficult to pass); (2) Sausage-shaped but lumpy; (3) Like a sausage but with cracks on its surface; (4) Like a sausage or snake, smooth and soft; (5) Soft blobs with clear-cut edges (passed easily); (6) Fluffy pieces with ragged edges, a mushy stool; (7) Watery, no solid pieces, entirely liquid.
Measured: From baseline to day 14, day 42 and day 84
Hospital Anxiety and Depression Scale / HADS
Changes at each timepoint of assessment in comparison to baseline. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Measured: From baseline to day 14, day 42 and day 84
SF-12: 12-item Short Form survey
Changes at each timepoint of assessment in comparison to baseline. The SF-12 consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.
Measured: From baseline to day 42 and day 84
Global evaluation of tolerability by subject and investigator
Changes in comparison to baseline. 8 weeks after the baseline, the subjects and the investigator will rate the tolerability of the IP by means of a global scaled evaluation with "very good", "good", "moderate" and "poor"
Measured: From baseline to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start21 Jul 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment randomized, double-blind, placebo-controlled, parallel group, single center trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- A-Mansia Biotech S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, A-Mansia Biotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348642
- Sponsor's protocol ID
- A-M/001322-2
- Status last verified
- Mar 2023
- First submitted
- 11 Apr 2022
- Last updated
- 2 Mar 2023
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effect of Pasteurized Akkermansia Muciniphila (pAkk) on Complaints Related to Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05348642
- Acronym / sponsor ID
- A-M/001322-2
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- A-Mansia Biotech S.A.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 27 Apr 2022 (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.
Double-blind, randomised, placebo-controlled study to evaluate the benefit of pasteurized Akkermansia muciniphila in reducing complaints related to irritable bowel syndrome.
Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability.
Detailed description
Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction, globally affecting about 10% of the population. Typical predominant traits are abdominal pain and abnormal bowel habits. The use of probiotics in IBS has been continuously assessed; in recent systematic reviews and meta-analyses, single or combined probiotic strains were indicated to have beneficial effects and good tolerability in the affected population.
pAkk has recently been assessed as a safe novel food ingredient. Beneficial effects and very good tolerability of pAkk have been reported in individuals with metabolic disorders. The objective of the present clinical study - a double-blind, randomised, placebo-controlled, parallel group design, explorative pilot 12-week nutritional study, is to assess the potential of pAkk in IBS management.
The main study objective is then to evaluate the benefit of pAkk in reducing complaints related to irritable bowel syndrome. Further objectives are to evaluate the beneficial potential of pAkk on any anxiety and depression complaints, as well as its safety and tolerability. In total, 90 participants will be enrolled and will attend 4 study visits: one on site and 3 televisits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment randomized, double-blind, placebo-controlled, parallel group, single center trial
| Arm | Type | Receives |
|---|---|---|
| Experimental group receiving pasteurized Akkermansia muciniphila | Experimental | Dietary Supplement: pasteurized A. muciniphilapasteurized Akkermansia muciniphila - daily oral dose |
| Control group | Placebo comparator | Dietary Supplement: placeboControl group receiving placebo, identical to verum regarding the form, size, taste, color and intake. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Men and women from 18 to 70 years old
- Meeting Rome-IV criteria for IBS:
- Recurrent abdominal pain on average ≥1 day/ week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria:
- Consistent and stable body weight in the last 3 months prior to study (less than 5% self-reported change)
- Having access to a smartphone or a computer with an internet access, either allowing a video call, and familiar with the use thereof (checked during the visit)
Key exclusion criteria (28 listed)
- Self-reported known allergy or hypersensitivity to any of the components of the investigational product
- Self-reported nocturnal GI complaints
- Women of childbearing potential: self-reported GI complaints mainly related to menstruation
- Self-reported lactose or fructose intolerance
- Self-reported acute or chronic significant GI disease or digestion/absorption disorders (e.g. inflammatory bowel disease, coeliac disease, pancreatitis, disorders in digestive tract motility etc.)
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 |
|---|---|---|
| pasteurized A. muciniphilapasteurized A. muciniphila - oral daily dose | Dietary supplement | Experimental group receiving pasteurized Akkermansia muciniphila |
| placeboPlacebo = identical to verum regarding the form, size, taste, color and intake | Dietary supplement | Control group |
Primary outcome
Irritable Bowel Severity Scoring System / IBS-SSS
Time frame: From baseline to day 14, day 42 and day 84
Changes at each timepoint of assessment in comparison to baseline. IBS-SSS is between 0 and 500, with a higher score meaning more severe symptoms.
6 secondary outcomes
Irritable Bowel Syndrome-Global Improvement Scale / IBS-GIS
Time frame: From baseline to day 14, day 42 and day 84
3-day diary data on stool frequency
Time frame: From baseline to day 84
3-day diary data on stool consistency (Bristol Stool Form Scale / BSFS)
Time frame: From baseline to day 14, day 42 and day 84
Hospital Anxiety and Depression Scale / HADS
Time frame: From baseline to day 14, day 42 and day 84
SF-12: 12-item Short Form survey
Time frame: From baseline to day 42 and day 84
Global evaluation of tolerability by subject and investigator
Time frame: From baseline to day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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. This study is not recruiting at the moment.
Study Director study director
A-Mansia Biotech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pasteurized A. muciniphila in people with Irritable Bowel Syndrome, run by A-Mansia Biotech S.A. at 1 site in Germany.
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 17 inclusion and 28 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: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Severity Scoring System / IBS-SSS (time frame: From baseline to day 14, day 42 and day 84). 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 Mar 2023.