IBS, Constipation PredominantNCT07094035
The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation
A study testing food supplement based on a mixture of green tea extract and a pool of probiotics. in people with IBS, Constipation Predominant, run by Adamas Biotech S.r.l. at 1 site in Italy.
Trial summary
The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS, Constipation Predominant
- What is being tested?
- food supplement based on a mixture of green tea extract and a pool of probiotics.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 70 years
- able to understand and sign informed consent
- HIV negative test
- negative pregnancy test
- With IBS symptoms for at least 3 months (with onset at least 6 months earlier)
- recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria)
Show all 13Show fewer
- who have less than three BM/wk and at least one of the following conditions:
- in more than 25%* of defecatory acts
- lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements
- feeling of incomplete evacuation in more than 25% of defecations
- feeling of anorectal obstruction/blockage in more than 25% of defecations
- carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations
- Able to understand and comply with the requirements of the protocol.
Who cannot join
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
COMEGEN Soc. Coop. Sociale
Naples, 80126
Matteo Laringe, + 39 081/6174566, comegen@comegen.org
About this study
Official title: Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.
The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life.
The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.
Read the detailed description
The IBS-THE-PROB25 study aims to understand whether a food supplement based on green tea and a mix of probiotics can help people suffering from Irritable Bowel Syndrome with constipation (IBS-C). The main goal is to see if this supplement improves the overall symptoms perceived by people with IBS-C.
Study participants are between 18 and 70 years old and have symptoms of IBS-C for at least 3 months, with constipation problems such as going to the bathroom less than 3 times a week and often having hard stools. There are also criteria why some people will not be able to participate, such as those who have other intestinal diseases or take certain medications.
Participants will be randomly divided into two groups. One group will take the supplement with green tea and probiotics, the other group will take a placebo (an inactive substance that looks the same as the supplements). In particular, the study plans to recruit 64 subjects (32 subjects per group), who will be randomized into the following experimental groups:
GROUP 1 (32 subjects) subjects who will have to take the food supplement, an extract of green tea (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis) GROUP 2 (32 subjects) subjects who will have to take placebo. Each subject of the two experimental groups before, during and after the administration of the dietary supplement or placebo, will undergo the evaluation of the primary and secondary outcomes. Neither participants nor doctors will know who is taking what (double-blind study). Clinicians will collect information about participants symptoms through questionnaires.
Specifically, a questionnaire called IBS-SSS will be used to assess the overall severity of symptoms. Quality of life, stool consistency (using the Bristol Scale), frequency of bowel movements, frequency and intensity of specific symptoms such as bloating and pain, use of "rescue" medications (such as laxatives) and abdominal pain will also be taken into account. A small group of participants will also need to provide stool samples to analyze substances that indicate inflammation and to see if probiotics "colonize" the gut.
The data collected will be analyzed with statistical methods to compare the two groups and see if there are significant differences in symptoms.
The trial will be conducted at a single center: COMEGEN Soc. Coop. Sociale, located in Viale Maria Bakunin, 41 (Parco S. Paolo), 80126- Naples. The Principal Investigator of the study is Dr. Matteo Laringe, also affiliated with COMEGEN Soc. Coop. Social. Subjects enrolled in the study will be followed at this location for the duration of their participation.
- Conditions
- IBS, Constipation Predominant
- Being tested
- food supplement based on a mixture of green tea extract and a pool of probiotics., Placebo
- Keywords
- IBS, constipation predominant, Food Supplement, Green tea extract, probiotics
- Medical subject headings
- Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food supplement based on a mixture of green tea extract and a pool of probiotics.Dietary supplement
two capsules of food supplement (verum) or placebo, daily for 56 consecutive days. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10^9 UFC, Bifidobacterium lactis BL050 2x10^9 UFC, Lactobacillus plantarum PBS067 2x10^9 UFC), as a white capsule.
PlaceboDietary supplement
1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. The two colours are applied to maintain the binding.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1: active group who will take verum | Experimental | Subjects who will take the food supplement. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10^9 UFC, Bifidobacterium lactis BL050 2x10^9 UFC, Lactobacillus plantarum PBS067 2x10^9 UFC), as a white capsule. Receives: Dietary Supplement: food supplement based on a mixture of green tea extract and a pool of probiotics. |
| GROUP 2: subjects who will take PLACEBO | Placebo comparator | Subjects who will take daily: 1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.
Validated questionnaire for self-assessment of the severity of global gastrointestinal symptomatology characterizing IBS, IBS Severity Scoring System (IBS-SSS). The questionnaire consists of 5 items referring to: abdominal pain, bowel dysfunction and general well-being. It is commonly used as an outcome measure in clinical efficacy trials, due to its high sensitivity following treatment. The total score obtained allows to determine the severity of global gastrointestinal symptoms, whether IBS-related symptoms are mild, moderate or severe and whether, following treatment, there is an improvement in global symptoms in the treated group compared to the placebo group.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
Secondary outcomes (8)
Assessment of the impact of constipation on perceived quality of life in the last 4 weeks
Quality of Life Questionnaire (Short Form Health Survey-12 -SF-12) was developed in a multiyear study of patients with chronic conditions. It is a validated questionnaire widely used in clinical practice for self-assessment of quality of life against a generic disorder. The SF-12 questionnaire allows you to describe the health of a subject through two synthetic indices calculated on 12 questions. The index called Physical Component Summary (PCS), concerns the physical state, while the Mental Component Summary (MCS) index measures the mental state.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness in improving stool consistency.
Bristol Stool Form Scale (BSFS), a validated instrument that assesses stool consistency on a spectrum of seven types. Type 1 and 2 stools denote hard or lumpy stools, while type 6 and 7 stools are indicative of loose or watery stools. The stools that characterize subjects with intestinal hyperactivity are type 5, 6, 7. Stool consistency will be reported by the subject at visits and reported, during the study period, on the Bowel Function Diary.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness of the frequency of bowel movements.
Number of bowel movements/week (BM/WK) will be reported by the subject at the visits (average BM/week over the previous 4 weeks) and reported, during the study period, on the bowel function diary.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS.
The assessment of the frequency and intensity characteristics of the subject with constipated IBS form (feeling of bloating, abdominal distension, feeling of fullness, abdominal pain, flatulence) will be determined through the compilation of a 5-point Likert scale (0 no discomfort - 5 maximum discomfort), present within the bowel function diary. Daily registration is useful to avoid the "recall" bias that could occur when filling out questionnaires at pre-arranged visits.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness of the decrease in frequency in the use of salvage treatments.
The evaluation of the frequency of use of salvage treatments, such as drugs for bowel function, laxatives or antispasmodics, will be recorded through the compilation of the bowel function diary.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The efficacy against abdominal pain to be evaluated separately from intestinal discomfort.
Visual Analogue Scale (VAS). It is a self-assessment tool for pain, used for several purposes and in the assessment of general pain in patients accessing the emergency room. It consists of a 10 cm strip of paper, which at both ends has the two endpoints "no pain" and "worst pain I can imagine", the patient must mark the level of perceived pain on the strip.
Measured: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
Evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin
Investigation carried out on stool samples. This analysis will be carried out on a pool of 30 subjects, 15 from the treatment group and 15 from the placebo group.
Measured: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]
Probiotic colonization rate.
Relative abundance of microbial species presents in the treatment (L. plantarum, L. rhamnosus, and B. animalis subsp. lactis) to assess the colonization ability of the study treatment. Investigation carried out on stool samples. This analysis will be carried out on a pool of 30 subjects, 15 from the treatment group and 15 from the placebo group.
Measured: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start30 Jul 2025
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS, Constipation PredominantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adamas Biotech S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094035
- Sponsor's protocol ID
- IBS-THE-PROB25
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT07094035
- Acronym / sponsor ID
- IBS-THE-PROB25
- Conditions
- IBS, Constipation Predominant
- Keywords
- IBS, constipation predominant, Food Supplement, Green tea extract, probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Adamas Biotech S.r.l.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 30 Jul 2025 (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 study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life.
The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.
Detailed description
The IBS-THE-PROB25 study aims to understand whether a food supplement based on green tea and a mix of probiotics can help people suffering from Irritable Bowel Syndrome with constipation (IBS-C). The main goal is to see if this supplement improves the overall symptoms perceived by people with IBS-C.
Study participants are between 18 and 70 years old and have symptoms of IBS-C for at least 3 months, with constipation problems such as going to the bathroom less than 3 times a week and often having hard stools. There are also criteria why some people will not be able to participate, such as those who have other intestinal diseases or take certain medications.
Participants will be randomly divided into two groups. One group will take the supplement with green tea and probiotics, the other group will take a placebo (an inactive substance that looks the same as the supplements). In particular, the study plans to recruit 64 subjects (32 subjects per group), who will be randomized into the following experimental groups:
GROUP 1 (32 subjects) subjects who will have to take the food supplement, an extract of green tea (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis) GROUP 2 (32 subjects) subjects who will have to take placebo. Each subject of the two experimental groups before, during and after the administration of the dietary supplement or placebo, will undergo the evaluation of the primary and secondary outcomes. Neither participants nor doctors will know who is taking what (double-blind study). Clinicians will collect information about participants symptoms through questionnaires.
Specifically, a questionnaire called IBS-SSS will be used to assess the overall severity of symptoms. Quality of life, stool consistency (using the Bristol Scale), frequency of bowel movements, frequency and intensity of specific symptoms such as bloating and pain, use of "rescue" medications (such as laxatives) and abdominal pain will also be taken into account. A small group of participants will also need to provide stool samples to analyze substances that indicate inflammation and to see if probiotics "colonize" the gut.
The data collected will be analyzed with statistical methods to compare the two groups and see if there are significant differences in symptoms.
The trial will be conducted at a single center: COMEGEN Soc. Coop. Sociale, located in Viale Maria Bakunin, 41 (Parco S. Paolo), 80126- Naples. The Principal Investigator of the study is Dr. Matteo Laringe, also affiliated with COMEGEN Soc. Coop. Social. Subjects enrolled in the study will be followed at this location for the duration of their participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1: active group who will take verum | Experimental | Dietary Supplement: food supplement based on a mixture of green tea extract and a pool of probiotics.Subjects who will take the food supplement. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10^9 UFC, Bifidobacterium lactis BL050 2x10^9 UFC, Lactobacillus plantarum PBS067 2x10^9 UFC), as a white capsule. |
| GROUP 2: subjects who will take PLACEBO | Placebo comparator | Dietary Supplement: PlaceboSubjects who will take daily: 1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- aged between 18 and 70 years
- able to understand and sign informed consent
- HIV negative test
- negative pregnancy test
- With IBS symptoms for at least 3 months (with onset at least 6 months earlier)
Key exclusion criteria (4 listed)
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
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 based on a mixture of green tea extract and a pool of probiotics.two capsules of food supplement (verum) or placebo, daily for 56 consecutive days. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10^9 UFC, Bifidobacterium lactis BL050 2x10^9 UFC, Lactobacillus plantarum PBS067 2x10^9 UFC), as a white capsule. | Dietary supplement | GROUP 1: active group who will take verum |
| Placebo1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. The two colours are applied to maintain the binding. | Dietary supplement | GROUP 2: subjects who will take PLACEBO |
Primary outcome
Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
Validated questionnaire for self-assessment of the severity of global gastrointestinal symptomatology characterizing IBS, IBS Severity Scoring System (IBS-SSS). The questionnaire consists of 5 items referring to: abdominal pain, bowel dysfunction and general well-being. It is commonly used as an outcome measure in clinical efficacy trials, due to its high sensitivity following treatment. The total score obtained allows to determine the severity of global gastrointestinal symptoms, whether IBS-related symptoms are mild, moderate or severe and whether, following treatment, there is an improvement in global symptoms in the treated group compared to the placebo group.
8 secondary outcomes
Assessment of the impact of constipation on perceived quality of life in the last 4 weeks
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness in improving stool consistency.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness of the frequency of bowel movements.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The effectiveness of the decrease in frequency in the use of salvage treatments.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
The efficacy against abdominal pain to be evaluated separately from intestinal discomfort.
Time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
Evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin
Time frame: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]
Probiotic colonization rate.
Time frame: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
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 based on a mixture of green tea extract and a pool of probiotics. in people with IBS, Constipation Predominant, run by Adamas Biotech S.r.l. at 1 site in Italy.
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 13 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Baldi (+393483854114, alessandra.baldi.alimenti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms. (time frame: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2025.