Study to asess the efects of Iberogast® and Iberogast® N in intestinal gas transit and abdominal symptoms of patients suffering from irritable bowel syndrom or functional dyspsia.

EFFECT OF STW5 (Iberogast ®) AND STW5-II (Iberogast N®) ON TRANSIT AND TOLERANCE OF INTESTINAL GAS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003976-38-ES

Enrollment

Registered

2020-01-14

Start date

2020-04-23

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome and functional dyspepsia MedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10064536 Term: Functional dyspepsia System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Iberogast® Pharmaceutical Form: Oral drops, solution INN or Proposed INN: MATRICARIA RECUTITA L. FLOS Current Sponsor code: MATRICARIA RECUTITA L. FLOS Other descriptive name: MATRICARIA R

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subject has read and signed the Institutional Review Board-approved Informed Consent form before Screening. 2. =18 years old. 3. Confirmed Irritable Bowel Syndrome (IBS) or Functional Dyspepsia (FD) diagnosis per Rome IV criteria. 4. Has active symptoms of bloating. 5. Subject must be willing to comply with the protocol. 6. Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study*. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Presence of any organic gastrointestinal diseases. 2. Subjects with known hypersensitivity to Iberogast or one of the active substances or excipients. 3. One or more medical condition(s), including renal, hepatic, hematologic, endocrinological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this study. 4. Malignant disease not in remission. 5. Presence of any active infectious disease. 6. Subjects not willing to stop medications that may interfere with gastrointestinal motility during 48 h previous to the gas infusion tests. These include: bulking agents, laxatives, linaclotide, prokinetics, antidiarrheal or opioids. 7. Known alcohol or drug abuse. 8. Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception. 9. Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effect of STW5 and STW5-II on transit and evacuation of intestinal gas in subjects with functional dyspepsia and irritable bowel syndrome according to Rome IV criteria.;Secondary Objective: 1.To determine if treatment with STW5 accelerates transit and evacuation of colonic gas, and improves gas tolerance in subjects with irritable bowel syndrome. 2.To determine if treatment with the new formulation STW5-II (Iberogast-N) accelerates transit and evacuation of colonic gas and improves gas tolerance in subjects with irritable bowel syndrome. 3.To determine if treatment with STW5 accelerates transit and evacuation of gastric gas and improves gas tolerance in subjects with functional dyspepsia. 4.To determine if treatment with STW5-II accelerates transit and evacuation of gastric gas, and improves gas tolerance in subjects with functional dyspepsia.;Primary end point(s): To compare final gas retention (calculated as total gas infused minus total gas evacuated) after a gas challenge test performed after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo.;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment.	—

Measure

Time frame

Main Objective: To determine the effect of STW5 and STW5-II on transit and evacuation of intestinal gas in subjects with functional dyspepsia and irritable bowel syndrome according to Rome IV criteria.;Secondary Objective: 1.To determine if treatment with STW5 accelerates transit and evacuation of colonic gas, and improves gas tolerance in subjects with irritable bowel syndrome. 2.To determine if treatment with the new formulation STW5-II (Iberogast-N) accelerates transit and evacuation of colonic gas and improves gas tolerance in subjects with irritable bowel syndrome. 3.To determine if treatment with STW5 accelerates transit and evacuation of gastric gas and improves gas tolerance in subjects with functional dyspepsia. 4.To determine if treatment with STW5-II accelerates transit and evacuation of gastric gas, and improves gas tolerance in subjects with functional dyspepsia.;Primary end point(s): To compare final gas retention (calculated as total gas infused minus total gas evacuated) after a gas challenge test performed after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo.;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): To compare the perception of abdominal symptoms induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo. To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo.;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment.	—

Measure

Time frame

Secondary end point(s): To compare the perception of abdominal symptoms induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo. To compare the objective abdominal distension (measured by a tape measure) induced by the gas challenge test after 2 weeks treatment with Iberogast® or Iberogast® N vs placebo.;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment.

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Countries

Spain

Contacts

Public ContactCRO

FLS-Research support

afiguerola@fls-rs.com+3493497 84 14

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 9, 2026