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

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ClinicalTrials.gov Identifier: NCT04656730
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
Bayer Hispania, S.L
Information provided by (Responsible Party):
Dr. Jordi Serra Pueyo, Hospital Vall d'Hebron

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Functional Dyspepsia Drug: Iberogast® and Iberogast® N Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Double (Participant, Investigator)
Masking Description: Experimental group: Study 1: STW5 20 drops TID; Study 2: STW5-II 20 drops TID Control group: Placebo 20 drops TID
Primary Purpose: Treatment
Official Title: Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Study 1: Experimental: Study 2: Experimental
Iberogast® (STW5) or Iberogast® N (STW5-II) 20 drops TID per 14 days
Drug: Iberogast® and Iberogast® N
Oral intake of the investigation drug 20 drops three times per day (TID) for 14 days,
Other Name: active

Placebo Comparator: Study 1: Comparator Study 2: Comparator
Placebo 20 drops TID per 14 days
Drug: Iberogast® and Iberogast® N
Oral intake of the investigation drug 20 drops three times per day (TID) for 14 days,
Other Name: active




Primary Outcome Measures :
  1. Transit and evacuation of intestinal gas [ Time Frame: Baseline to Day 14 ]

    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).



Secondary Outcome Measures :
  1. Perception of abdominal symptoms [ Time Frame: Baseline to Day 14 ]
    To determine the independent effects of STW5 and STW5-II, compared to respective placebos, on subjective perception of abdominal symptoms (measured by a graded symptom scale) in response to colonic gas infusion in subjects with irritable bowel syndrome and functional dyspepsia.

  2. Objective abdominal distension [ Time Frame: Baseline to Day 14 ]
    To determine the independent effects of STW5 and STW5-II, compared to respective placebos, on objective abdominal distension (measured in mm by a tape-measure) in response to colonic gas infusion in subjects with irritable bowel syndrome and functional dyspepsia.

  3. Adverse events [ Time Frame: Baseline to Day 14 ]
    To determine the adverse events that occur during the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656730


Contacts
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Contact: JORDI SERRA, MD, PhD (34) 93 497 89 09 Jserrap.germanstrias@gencat.cat

Locations
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Spain
Germans Trias i Pujol Hospital Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Dr. JORDI F SERRA, MD,Phd    (34) 93 4978909    Jserrap.germanstrias@gencat.cat   
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Principal Investigator: Dr. Jordi Serra, MD,PhD         
Sponsors and Collaborators
Hospital Vall d'Hebron
Bayer Hispania, S.L
Investigators
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Principal Investigator: JORDI SERRA, MD, PhD Germans Trias i Pujol Hospital
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Responsible Party: Dr. Jordi Serra Pueyo, MD. PH D., Hospital Vall d'Hebron
ClinicalTrials.gov Identifier: NCT04656730    
Other Study ID Numbers: IBO
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jordi Serra Pueyo, Hospital Vall d'Hebron:
Digestive System Diseases
2. Gastrointestinal disorders
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Dyspepsia
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive