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

• Sponsor: Federal Stare Budgetary Scientific Institution, Mental Health Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04484467
• Collaborator: I.M. Sechenov First Moscow State Medical University (Other), RML INVEST, Torkhovsky passage 10, Tula, Russian Federation (Other)
• Enrollment: 56
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.6
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed	Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and Ginger; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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). 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).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). 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).
• Masking: Double (Participant, Investigator)
• Masking Description: Using a random number generator, 56 patients with IBS or IBS/FD were randomly assigned to either the intervention group (28 individuals) or control group (28 individuals). Researchers and patients were not informed who received a supplement or placebo.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 9, 2018
• Actual Primary Completion Date: Dec 28, 2019
• Actual Study Completion Date: Dec 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Food supplement Standart Zdorovya GASTRO 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.	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 Names: Standart Zdorovya GASTRO
Placebo Comparator: 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.	Other: Placebo; Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Research Center	Moscow		Russian Federation

Sponsors and Collaborators

• 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allan G. Beniashvilia, Senior research fellow, PHD, Federal Stare Budgetary Scientific Institution, Mental Health Research Center
• ClinicalTrials.gov Identifier: NCT04484467
• Other Study ID Numbers: No. 418 dated 01/31/2018
• First Posted: Jul 23, 2020
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Allan G. Beniashvilia, Senior research fellow, PHD, Federal Stare Budgetary Scientific Institution, Mental Health Research Center: Functional dyspepsia
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation; Diarrhea; Menthol

Study Results

No Results Posted as of Jul 29, 2020