Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed
• Interventions: Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and Ginger; Other: Placebo

• Registration Number: NCT04484467
• Lead Sponsor: Federal Stare Budgetary Scientific Institution, Mental Health Research Center

Brief Summary

The purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (IBS) or IBS/functional dyspepsia (FD).

Detailed Description

Using a random number generator, 56 patients meeting inclusion criteria with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or the control group (28 individuals) (Table 2). Non-functional causes for the symptoms were excluded by a detailed evaluation of the medical history, physical examination, extensive panel of blood tests, stool analysis, and colonoscopy with biopsies.

Diarrhoea-predominant IBS patients (IBS-D) and mixed bowel habits IBS patients (IBS-M) were treated with smooth muscle antispasmodics. The constipation-predominant IBS patients (IBS-C) were treated with smooth muscle antispasmodics and laxatives. IBS/FD patients were treated with smooth muscle antispasmodics and proton pump inhibitors.

At Visit 1, all patients were randomly assigned into two groups. In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days (Table 1). Researchers and patients were not informed who received a supplement or placebo. During the 30 days of the study, three outpatient visits were conducted (Visit 1 - Day 1, Visit 2 - Day 15 + 2 days, and Visit 3 - Day 30 + 2 days).

Symptom severity was assessed on each visit using "7x7" questionnaire \[Ivashkin, V., Sheptulin, A., Shifrin, O., Poluektova, E., Pavlov, C., Ivashkin, K., Drozdova, A., Lyashenko, O., Korolev, A., 2019. Clinical validation of the "7 × 7" questionnaire for patients with functional gastrointestinal disorders. J. Gastroenterol. Hepatol. 34, 1042-1048. https://doi.org/10.1111/jgh.14546\], on 1 and 3 visits stool samples were collected for the qualitative and quantitative composition of the intestinal microbiota based on 16S rRNA gene sequencing.

The study protocol was approved by the Ethics Committee of the Mental Health Research Center, Moscow, Russian Federation (No. 418 dated 01/31/2018) and written informed consent was obtained from all participants.

Study Timeline

• Study Start: 2018-02-09
• Primary Completion: 2019-12-28
• Study Completion: 2019-12-28
• Status Verified: 2020-07
• Study First Submitted: 2020-07-20
• Study First Submitted QC: 2020-07-20
• Study First Posted: 2020-07-23
• Last Update Submitted: 2020-07-26
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• irritable bowel syndrome (IBS)
• diarrhea-predominant IBS
• constipation-predominant IBS
• mixed-type IBS
• IBS/functional dyspepsia symptoms
• Must be able to swallow tablets

Exclusion Criteria

• organic bowel disease
• renal disease
• hepatic insufficiency,
• schizophrenia
• bipolar disorder
• epilepsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Food supplement Standart Zdorovya GASTRO	Food Supplement With Standardized Menthol, Limonene, and Ginger	In the intervention group (Group 1), the supplement "Standart Zdorovya GASTRO" (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.
Placebo	Placebo	In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days.

Primary Outcome Measures

Name	Time	Method
Change in the severity of symptoms of irritable bowel syndrome (IBS) and functional dyspepsia (FD) (constipation-predominant, diarrhea-predominant, mixed-type IBS and IBS/FD)	Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days	Symptom severity was tested with a "7x7" questionnaire at each visit.

Secondary Outcome Measures

Name	Time	Method
Change in the number of SCFA producing bacteria	Visit 1 - Day 1, Visit 3 - Day 30 + 2 days	The qualitative and quantitative composition of the intestinal microbiota was assessed at Visits 1 and 3 based on 16S rRNA gene sequencing.

Trial Locations

Locations (1)

Mental Health Research Center; 🇷🇺 Moscow, Russian Federation