Diarrhea- Irritable Bowel Syndrome Clinical Trial
Official title:
Clinical Study on the Effect of Neu-P11 on Symptoms in Patients With Diarrhea- Irritable Bowel Syndrome (D-IBS)
Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS, 20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.
This study aims to test a possible beneficial effect of NEU-P11 in patients with IBS.
The effect on symptoms will be rated by symptom scores. The primary endpoint will be the
symptomatic benefit reported by the patient answering the simple question: Did your symptoms
improve compared to prior to the clinical trial.
Additional secondary endpoints will capture sleep quality, changes in stool texture and
individual symptom scores employing standardized symptom scores.
The study design is a 4 week, randomised, placebo-controlled, double blind study where 40
patients receive either placebo (20) or NEU-P11 (20). In the mid of the four week time of
the Study the dose can be doubled of the patient does not recognize any relief of the D-IBS.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05941650 -
To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
|
N/A |