Irritable Bowel SyndromeNCT04484467
Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content in Patients With Irritable Bowel Syndrome
A study testing Food Supplement With Standardized Menthol, Limonene, and Ginger in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Federal Stare Budgetary Scientific Institution, Mental Health Research Center at 1 site in Russia.
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). Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation
- What is being tested?
- Food Supplement With Standardized Menthol, Limonene, and Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 9 Feb 2018to 28 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- irritable bowel syndrome (IBS)
- diarrhea-predominant IBS
- constipation-predominant IBS
- mixed-type IBS
- IBS/functional dyspepsia symptoms
- Must be able to swallow tablets
Who cannot join
- organic bowel disease
- renal disease
- hepatic insufficiency,
- schizophrenia
- bipolar disorder
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Being tested
- Food Supplement With Standardized Menthol, Limonene, and Ginger, Placebo
- Keywords
- Functional dyspepsia
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Supplement With Standardized Menthol, Limonene, and GingerDietary supplement
Also called Standart Zdorovya GASTRO
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
PlaceboOther
Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Food supplement Standart Zdorovya GASTRO | Experimental | 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. Receives: Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and Ginger |
| Placebo | Placebo comparator | In the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days
Secondary outcomes (1)
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.
Measured: Visit 1 - Day 1, Visit 3 - Day 30 + 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start9 Feb 2018
- Primary completion28 Dec 2019
- Study completion28 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Stare Budgetary Scientific Institution, Mental Health Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, RML INVEST, Torkhovsky passage 10, Tula, Russian Federation
- Responsible party
- Principal investigator, Allan G. Beniashvilia, Federal Stare Budgetary Scientific Institution, Mental Health Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484467
- Sponsor's protocol ID
- No. 418 dated 01/31/2018
- Status last verified
- Jul 2020
- First submitted
- 20 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ivashkin VT, Kudryavtseva AV, Krasnov GS, Poluektov YM, Morozova MA, Shifrin OS, Beniashvili AG, Mamieva ZA, Kovaleva AL, Ulyanin AI, Trush EA, Erlykin AG, Poluektova EA. 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. PLoS One. 2022 Jun 15;17(6):e0263880. doi: 10.1371/journal.pone.0263880. eCollection 2022.
PubMed 35704960
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04484467
- Acronym / sponsor ID
- No. 418 dated 01/31/2018
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Keywords
- Functional dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Federal Stare Budgetary Scientific Institution, Mental Health Research CenterUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University, RML INVEST, Torkhovsky passage 10, Tula, Russian Federation
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 28 Dec 2019 (actual)
- Study completion
- 28 Dec 2019 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Food supplement Standart Zdorovya GASTRO | Experimental | Dietary Supplement: Food Supplement With Standardized Menthol, Limonene, and GingerIn 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 comparator | Other: PlaceboIn the control group (Group 2), placebo (1 capsule, 730 mg, once a day) was added to the standard treatment regimen for 30 days. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- irritable bowel syndrome (IBS)
- diarrhea-predominant IBS
- constipation-predominant IBS
- mixed-type IBS
- IBS/functional dyspepsia symptoms
Key exclusion criteria (6 listed)
- organic bowel disease
- renal disease
- hepatic insufficiency,
- schizophrenia
- bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Supplement With Standardized Menthol, Limonene, and GingerAlso: Standart Zdorovya GASTROComponents 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 | Dietary supplement | Food supplement Standart Zdorovya GASTRO |
| PlaceboComponents of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days | Other | Placebo |
Primary outcome
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)
Time frame: 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.
1 secondary outcome
Change in the number of SCFA producing bacteria
Time frame: Visit 1 - Day 1, Visit 3 - Day 30 + 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 35704960Ivashkin VT, Kudryavtseva AV, Krasnov GS, Poluektov YM, Morozova MA, Shifrin OS, Beniashvili AG, Mamieva ZA, Kovaleva AL, Ulyanin AI, Trush EA, Erlykin AG, Poluektova EA. 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. PLoS One. 2022 Jun 15;17(6):e0263880. doi: 10.1371/journal.pone.0263880. eCollection 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement With Standardized Menthol, Limonene, and Ginger in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Federal Stare Budgetary Scientific Institution, Mental Health Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Visit 1 - Day 1, Visit 2 - Day 15 +- 2 days, and Visit 3 - Day 30 +- 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04484467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.