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

NCT04656730 | Completed Phase 4

• 1 other identifier: IBO
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Irritable Bowel Syndrome; Functional Dyspepsia

Keywords

Digestive System Diseases; 2. Gastrointestinal disorders

Outcome Measures

Primary Outcomes (1)

• Transit and evacuation of intestinal gas

  Colonic gas filling and evacuation (patients with irritable bowel síndrome) and Gastric gas transit (patients with functional dispepsia). Primary outcome measures will be evaluated by an infusion machine (to perform gas infusion) and a barostat (to perform gas collection measurement).

  Baseline to Day 14

Secondary Outcomes (3)

• Perception of abdominal symptoms

  Baseline to Day 14

• Objective abdominal distension

  Baseline to Day 14

• Adverse events

  Baseline to Day 14

Study Arms (2)

Study 1: Experimental: Study 2: Experimental

EXPERIMENTAL

Iberogast® (STW5) or Iberogast® N (STW5-II) 20 drops TID per 14 days

Drug: Iberogast® and Iberogast® N

Study 1: Comparator Study 2: Comparator

PLACEBO COMPARATOR

Placebo 20 drops TID per 14 days

Drug: Iberogast® and Iberogast® N

Interventions

Iberogast® and Iberogast® N DRUG

Oral intake of the investigation drug 20 drops three times per day (TID) for 14 days,

Also known as: active

Study 1: Comparator Study 2: Comparator; Study 1: Experimental: Study 2: Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has read and signed the institutional review board-approved informed consent form before screening.
• ≥18 years old.
• Confirmed irritable bowel syndrome (ibs) or functional dyspepsia (fd) diagnosis per rome iv criteria.
• Has active symptoms of bloating.
• Subject must be willing to comply with the protocol.
• 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.

You may not qualify if:

• Presence of any organic gastrointestinal diseases.
• Subjects with known hypersensitivity to Iberogast or one of the active substances or excipients.
• 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.
• Subjects with impaired liver function tests
• Malignant disease not in remission.
• Presence of any active infectious disease.
• 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.
• Known alcohol or drug abuse.
• Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception.
• Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits.

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead
• Bayer Hispania, S.L: collaborator

Study Sites (2)

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Digestive System Diseases

Interventions

iberogast; Exercise

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• JORDI SERRA, MD, PhD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Experimental group: Study 1: STW5 20 drops TID; Study 2: STW5-II 20 drops TID Control group: Placebo 20 drops TID
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PH D.

Model Details: To determine the independent effects 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, measured as ml of gas recovered by a rectal cannula

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 7, 2020
• Study Start: September 3, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

ES (2)