Irritable Bowel Syndrome With ConstipationKombuchaNCT05164861
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
A study testing kombucha-based beverage in people with Irritable Bowel Syndrome With Constipation and Constipation-predominant Irritable Bowel Syndrome, run by Vasily Isakov at 1 site in Russia.
Trial summary
Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- kombucha-based beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2021to 28 Jul 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willingness to participate (based on signed informed consent form)
- irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),
Who cannot join
- pregnant or breast-feeding women;
- intolerance of kombucha or any component of the product;
- history of abdominal surgery;
- the use of concomitant medications able to affect bowel motility;
- general condition of a patient making the appropriateness of his participation in the study questionable;
- chronic decompensated disorders of any organs and systems;
- mean daily caloric intake less than 800 kcal and more than 6000 kcal
- inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, 115446
About this study
Official title: Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations
Read the detailed description
This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.
- Conditions
- Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome
- Being tested
- kombucha-based beverage
- Keywords
- specialized food product, kombucha, safety, efficacy, constipation, functional food
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kombucha-based beverageDietary supplement
Also called Kombucha enriched with inulin, vitamins and flavours
kombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%*), vitamin B1 - 0.4 mg (29%*), B2 - 0.21 mg (13%*), B6 - 0.48 mg (24%*), niacin - 2.74 mg (15%*), folic acid - 24.0 mcg (12%*). Energy value/Caloric content - 54 kilojoules/13 kcal (* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries \& juniper berries, or strawberries \& lime leaves, or passion fruit \& mango.
Portion's volume - 220 ml. Daily intake: 1 portion
| Study group | Role | What they receive |
|---|---|---|
| Intervention/kombucha-based beverage | Experimental | Subjects randomized to this group will receive newly developed food product - non-alcoholic pasteurized beverage based on kombucha enriched with inulin and vitamins, flavoured as "Black currant with juniper" or "Strawberries with lime" or 'Mango with passion fruit" Receives: Dietary Supplement: kombucha-based beverage |
| Control | No intervention | Subjects of this group will receive standard diet with similar quantity of water as in experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of number bowel movements
Number of bowel movements per week will be assessed per patients self report
Measured: two weeks
Change of stool type
Stool type assessed per the Bristol stool scale (from type 1 to type 7; where type 1 - separate hard lumps, like nuts, type 7 - watery, no solid pieces, entirely liquid stool - diarrhoea)
Measured: a week
Secondary outcomes (1)
Adverse events
Number of adverse events
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Nov 2021
- Primary completion31 Jan 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vasily Isakov
- Sponsor type
- University, hospital or other
- Collaborators
- Azbuka vkusa, Russian Science Foundation, Federal State Budgetary Scientific Institution
- Responsible party
- Sponsor-investigator, Vasily Isakov, Russian Academy of Medical Sciences
- Investigators
- Vasily Isakov, Professor, Principal investigator, Federal Research Center of Nutrition and Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164861
- Sponsor's protocol ID
- 19-76-30014/2021K-OGIG
- Acronym
- Kombucha
- Status last verified
- Sep 2023
- First submitted
- 4 Dec 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Blinded to personal data individual participant data may be shared per reasonable request after study completion
Publications
Isakov VA, Pilipenko VI, Vlasova AV, Kochetkova AA. Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study. Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec.
PubMed 38149073Pilipenko VI, Isakov VA, Morozov SV, Vlasova AV, Kochetkova AA. [Efficacy of newly developed kombucha-based specialized food product for treatment of constipation-predominant irritable bowel syndrome]. Vopr Pitan. 2022;91(5):95-104. doi: 10.33029/0042-8833-2022-91-5-95-104. Epub 2022 Aug 30. Russian.
PubMed 36394933
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
- ClinicalTrials.gov ID
- NCT05164861
- Acronym / sponsor ID
- Kombucha / 19-76-30014/2021K-OGIG
- Conditions
- Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome
- Keywords
- specialized food product, kombucha, safety, efficacy, constipation, functional food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vasily IsakovUniversity, hospital or other
- Collaborators
- Azbuka vkusa, Russian Science Foundation, Federal State Budgetary Scientific Institution
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 21 Dec 2021 (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.
Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations
Detailed description
This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/kombucha-based beverage | Experimental | Dietary Supplement: kombucha-based beverageSubjects randomized to this group will receive newly developed food product - non-alcoholic pasteurized beverage based on kombucha enriched with inulin and vitamins, flavoured as "Black currant with juniper" or "Strawberries with lime" or 'Mango with passion fruit" |
| Control | No intervention | –Subjects of this group will receive standard diet with similar quantity of water as in experimental group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to participate (based on signed informed consent form)
- irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),
Key exclusion criteria (8 listed)
- pregnant or breast-feeding women;
- intolerance of kombucha or any component of the product;
- history of abdominal surgery;
- the use of concomitant medications able to affect bowel motility;
- general condition of a patient making the appropriateness of his participation in the study questionable;
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 |
|---|---|---|
| kombucha-based beverageAlso: Kombucha enriched with inulin, vitamins and flavourskombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%*), vitamin B1 - 0.4 mg (29%*), B2 - 0.21 mg (13%*), B6 - 0.48 mg (24%*), niacin - 2.74 mg (15%*), folic acid - 24.0 mcg (12%*). Energy value/Caloric content - 54 kilojoules/13 kcal (* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries \& juniper berries, or strawberries \& lime leaves, or passion fruit \& mango. Portion's volume - 220 ml. Daily intake: 1 portion | Dietary supplement | Intervention/kombucha-based beverage |
Primary outcome
Change of number bowel movements
Time frame: two weeks
Number of bowel movements per week will be assessed per patients self report
Change of stool type
Time frame: a week
Stool type assessed per the Bristol stool scale (from type 1 to type 7; where type 1 - separate hard lumps, like nuts, type 7 - watery, no solid pieces, entirely liquid stool - diarrhoea)
1 secondary outcome
Adverse events
Time frame: two weeks
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 6 Sep 2023.
- Derived from this study: PubMed 38149073Isakov VA, Pilipenko VI, Vlasova AV, Kochetkova AA. Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study. Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec.
- Derived from this study: PubMed 36394933Pilipenko VI, Isakov VA, Morozov SV, Vlasova AV, Kochetkova AA. [Efficacy of newly developed kombucha-based specialized food product for treatment of constipation-predominant irritable bowel syndrome]. Vopr Pitan. 2022;91(5):95-104. doi: 10.33029/0042-8833-2022-91-5-95-104. Epub 2022 Aug 30. Russian.
- Rome IV criteriaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Blinded to personal data individual participant data may be shared per reasonable request after study completion
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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.
Vasily Isakov, Professor principal investigator
Federal Research Center of Nutrition and Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kombucha-based beverage in people with Irritable Bowel Syndrome With Constipation and Constipation-predominant Irritable Bowel Syndrome, run by Vasily Isakov 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 2 inclusion and 8 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 6 Sep 2023. 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. 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 of number bowel movements (time frame: two weeks). The study lists 2 primary outcomes in all. 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 NCT05164861, which also lists 2 linked publications.
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 6 Sep 2023.