interventional
N/A
2 countries
11
The objectives are to systematically assess symptom changes and tolerability during treatment with Menthacarin and to explore their impact on quality of life and treatment satisfaction in a broad population of patients with functional gastrointestinal disorders. Furthermore, parameters related to gut permeability will be determined.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2022
Actual (reported)Symptom rating by the patient using 11-point numeric rating scales,
The sum of patient symptom rating of all abdominal symptoms,
Global question on symptom impact,
Most bothersome abdominal symptom,
Stool frequency via Frequency of Spontaneous Bowel Movements (SBMs),
Stool consistency via Bristol Stool Scale,
Satisfaction with change in bowel habits,
Global assessment of effectiveness, on a 5-point Likert scale
Patient´s satisfaction using the Integrative Medicine Patient Satisfaction Scale (IMPSS),
Quality of Life Questionnaire (SF 12),
Patient’s willingness to recommend Menthacarin,
Serum parameters: Zonulin and Intestinal-fatty acid binding protein (I-FABP)
Adverse events
Global assessment of tolerability on a 5-point Likert scale
Due to the character of the trial, no differentiation in primary and secondary outcome variables is intended
Gemeinschaftspraxis Nittendorf
Nittendorf, 93152, Germany
Praxis Dr. med. Manuela Thinesse-Mallwitz
Munich, 80339, Germany
Gemeinschaftspraxis Dr. med. Josef und Dr. med. Wilma Großkopf
Wallerfing, 94574, Germany
Annette Waßmer
First Submitted
December 29, 2022
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders
Contact the study team to confirm eligibility.
MVZ im Altstadt-Carree Fulda GmbH Medizinisches Versorgungszentrum
Fulda, 36037, Germany
Centrum Gastroenterologie Bethanien
Frankfurt am Main, 60389, Germany
Sozialstiftung Bamberg
Bamberg, 96049, Germany
Internisten Werden – Hausaerztliche Gemeinschaftspraxis
Essen-Werden, 45239, Germany
Hausarztliches MVZ Dr. Landers GmbH
Mayen, 56727, Germany
Eugastro GmbH
Leipzig, 04103, Germany
medicoKIT GmbH
Goch, 47574, Germany
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
Leipzig, 04249, Germany