ESCHERICHIA COLI DSM 17252 for Irritable bowel syndrome|Diarrhea-predominant irritable bowel syndrome (IBS-D)

Inclusion criteria

• {"criterion_text":"- Male or female outpatients aged ≥18 years"}
• {"criterion_text":"- Diagnosis of irritable bowel syndrome according to Rome IV: 1. Recurrent abdominal pain, on average, at least 1 day per week in the last 3 months associated with two or more of the following criteria: - Related to defecation - Associated with a change in frequency of stool - Associated with a change in form (appearance) of stool 2. Criteria fulfilled for the last 3 months and 3. IBS symptom onset ≥6 months 4. IBS-D subtype with abnormal stools being usually diarrhoea"}
• {"criterion_text":"- Colonoscopy with no clinically relevant findings (performed for all patients younger than 50 years and for patients ≥50 years of age within the last 5 years)"}
• {"criterion_text":"- Female patients of childbearing potential must be either surgically sterilized or use a highly effective method of contraception with a negative pregnancy test at screening and baseline/day 0"}
• {"criterion_text":"- Willingness to refrain from significant changes in diet, fibre intake, fluid intake, or physical activity during the study"}
• {"criterion_text":"- Willingness to refrain from the use of other medications for IBS treatment, including probiotic medication"}
• {"criterion_text":"- Ability to comply with treatment"}
• {"criterion_text":"- Sufficient knowledge of German language to understand trial instructions and rating scales"}
• {"criterion_text":"- Written informed consent prior to enrolment"}
• {"criterion_text":"- Email account and internet access available"}

Exclusion criteria

• {"criterion_text":"- History of abdominal surgery within the 6 months prior to screening"}
• {"criterion_text":"- Presence or suspected presence of unstable coronary artery disease, untreated organic gastrointestinal disease and uncontrolled metabolic diseases causing IBS-related symptoms, or collagen vascular disease within the 6 months prior to screening"}
• {"criterion_text":"- Lactose or fructose intolerance explaining the symptoms (in doubtful cases, a diagnostic test has to be performed)"}
• {"criterion_text":"- Coeliac disease (in doubtful cases, a diagnostic test has to be performed)"}
• {"criterion_text":"- Confirmed bile acid malabsorption by SeHCAT-Test or successful treatment by bile acid sequestrant"}
• {"criterion_text":"- Change of diet e.g. FODMAP, gluten-free within last 3 months"}
• {"criterion_text":"- Abnormal endoscopy/ abdominal ultrasound requiring further investigation"}
• {"criterion_text":"- Any alarm symptoms including uninvestigated anaemia, rectal bleeding, weight loss, or unresolved fever within the 6 months prior to screening"}
• {"criterion_text":"- Participation in another clinical trial or use of any investigational drug within 30 days or 5 half-lives (whichever is longer) before dosing"}
• {"criterion_text":"- Evidence of current or recent alcohol or drug abuse within 6 months prior to screening"}
• {"criterion_text":"- History or evidence of current laxative abuse"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Any illness or condition that might impact the safety of study drug administration or evaluability of drug effect based on Investigator’s discretion"}
• {"criterion_text":"- No consent to recording and processing of pseudonymised data according to legal requirements"}
• {"criterion_text":"- Patients who are committed to a clinic or similar institution by official or judicial order"}
• {"criterion_text":"- Hypersensitivity to active ingredient or any excipients of the medicinal product"}
• {"criterion_text":"- Current intake of prohibited medications except for rescue purposes (refer to 9.3)"}
• {"criterion_text":"- Serum potassium, magnesium, or calcium values outside the normal range at screening and clinically significant"}
• {"criterion_text":"- Serum aspartate transaminase (AST), alanine transaminase (ALT), or gamma glutamyl-transferase (GGT) ≥3 times the upper limit of the normal range at screening or baseline, or a bilirubin value ≥2 times the upper limit of the normal range at screening"}
• {"criterion_text":"- Abnormal thyroid stimulating hormone (TSH) value at screening, unless the free T4 value is normal; (Note: Levothyroxine will be allowed, if on stable dose for at least 30 days prior to screening and no changes expected during study)"}
• {"criterion_text":"- Any further laboratory value(s) outside the laboratory reference range at screening considered clinically significant by the Investigator"}

Primary endpoints

• {"endpoint_text":"- 1. Response rate measured by Bristol Stool Scale. BSS response is defined as at least 50% reduction in the number of days with at least one stool that has a consistency of 6 or 7 per week compared to baseline for a minimum of 13 of the 26 measurements (i.e. at least 50% improvement of stool consistency during treatment)","definition_or_measurement_approach":"BSS response defined as at least 50% reduction in number of days with stool consistency 6 or 7 per week compared to baseline for minimum of 13 of 26 measurements."}
• {"endpoint_text":"- 2. Response rate measured by the 11-point numeric rating scale (NRS). Abdominal Pain Intensity response is defined as a decrease in the weekly average of worst abdominal pain","definition_or_measurement_approach":"Abdominal Pain Intensity response measured by 11-point NRS; defined as a decrease in the weekly average of worst abdominal pain (text truncated in source)."}

Secondary endpoints

• {"endpoint_text":"- Response rate measured by the 7-point IBS Global Assessment of Improvement Scale (IBS-GAI) during the 26 weeks of treatment. IBS-GAI response is defined as at least 50% moderate or substantial improvement during the 26 weeks of treatment","definition_or_measurement_approach":"IBS-GAI response defined as at least 50% moderate or substantial improvement during 26 weeks of treatment."}
• {"endpoint_text":"- Response rate measured by the 11-point numeric rating scale during the 26 weeks of treatment. Response is defined as ≥30% improvement in Abdominal Pain Intensity weekly response compared to baseline for a minimum of 20 of the 26 measurements (i.e. 75% improvem","definition_or_measurement_approach":"Abdominal Pain Intensity weekly response defined as ≥30% improvement vs baseline for minimum of 20 of 26 measurements (text truncated in source)."}

Methods

• Social media adverts (documents: 'K2_Recruitment material Social Media', 'K2_Recruitment material Social Media Bruns Hannover') — digital advertising targeting potential participants (Germany).
• Landing pages / Advertisement landingpage (documents: 'K2_Recruitment material Landingpage Bruns Hannover', 'K2_Recruitment material Landingpage Reimer Karlsruhe', 'K2_Recruitment material Advertisement landingpage') — web-based recruitment prescreening and information (Germany).
• Flyers and posters (documents: 'K2_Recruitment material Flyer Bruns Hannover', 'K2_Recruitment material Flyer poster', 'K2_Recruitment material Flyer poster print Reimer Karlsruhe') — local site-based printed materials (Germany).
• Call center outreach (documents: 'K2_Recruitment material call center CLEAN', 'K2_Recruitment material call center TC') — telephone-based outreach and pre-screening (Germany).
• Patient letters / letter templates and patient letter database (documents: 'K2_Recruitment material Letter template Reimer Karlsruhe', 'K2_Recruitment material patient letter database Reimer Karlsruhe') — direct mail/email to potential participants (Germany).
• Prescreening tool / prescreening questions (document: 'K2_Recruitment material Prescreening tool questions') — online or phone prescreening of eligibility (Germany).
• Local adverts / recruitment adverts (document: 'K2_Recruitment material Advert', 'K2_Recruitment material Advertisement landingpage') — local and online advertising (Germany).

Germany

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

659

Number Of Sites

33

Number Of Participants

422

Primary sponsor

Full Name

SymbioPharm GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

AMS Advanced Medical Services GmbH

Responsibilities

sponsorDuties codes: 1,10,11,12,2,5,6,7 (operations/management roles as listed)

Name

SCRATCH Pharmacovigilance GmbH & Co. KG

Responsibilities

safety/pharmacovigilance (sponsorDuties code: 8)

Third parties

• {"country":"Germany","full_name":"AMS Advanced Medical Services GmbH","duties_or_roles":"sponsorDuties codes: 1,10,11,12,2,5,6,7 (as listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"SCRATCH Pharmacovigilance GmbH & Co. KG","duties_or_roles":"sponsorDuties codes: 8 (pharmacovigilance; as listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MVZ Medizinisches Labor Bremen GmbH","duties_or_roles":"sponsorDuties code: 15 (stool analysis)","organisation_type":"Laboratory/Research/Testing facility"}