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

Irritable Bowel Syndrome Clinical Trial

Official title:

Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome: a Double-blind, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484467
• Other study ID #: No. 418 dated 01/31/2018
• Status: Completed
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: December 28, 2019

Study information

• Verified date: July 2020
• Source: Federal Stare Budgetary Scientific Institution, Mental Health Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 28, 2019
• Est. primary completion date: December 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Mixed
• Irritable Bowel Syndrome With Constipation
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Dietary Supplement:
• Food Supplement With Standardized Menthol, Limonene, and Ginger
Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days

Other:
• Placebo
Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days

Locations

Country	Name	City	State
Russian Federation	Mental Health Research Center	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Federal Stare Budgetary Scientific Institution, Mental Health Research Center	I.M. Sechenov First Moscow State Medical University, RML INVEST, Torkhovsky passage 10, Tula, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Symptom severity was tested with a "7x7" questionnaire at each visit.	Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days
Secondary	Change in the number of SCFA producing bacteria	The qualitative and quantitative composition of the intestinal microbiota was assessed at Visits 1 and 3 based on 16S rRNA gene sequencing.	Visit 1 - Day 1, Visit 3 - Day 30 + 2 days