Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to asess the effects of Iberogast® (STW5) and Iberogast® N (STW5-II) in intestinal gas transit and abdominal symptoms of patients suffering from irritable bowel syndrome or functional dyspepsia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut Germans Trias i Pujol
• Collaborator: Bayer Hispania, S.L

Criteria

Inclusion Criteria:

1. 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*. *women of childbearing potential must have a negative pregnancy test prior to randomization into the study and commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, hormonal contraception, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study. based on ich, m3 (r2) 2009 a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. permanent sterilization methods include tubal ligation, hysterectomy, bilateral oophorectomy.

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. Subjects with impaired liver function tests

5. Malignant disease not in remission.

6. Presence of any active infectious disease.

7. 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.

8. Known alcohol or drug abuse.

9. Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception.

10. Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits.