Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation; Diarrhea
Study type: Interventional

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.
    

Intervention name(s): Food Supplement With Standardized Menthol, Limonene, and Ginger; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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; Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days
Other intervention name(s): Standart Zdorovya GASTRO
Intervention MeSH terms: Menthol
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).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Functional dyspepsia