Irritable Bowel SyndromeMASTIQUANCT04893499
A Study of Chios Mastic Water in Irritable Bowel Syndrome
A study testing Chios mastic water and Chios mastic fruit juice in people with Irritable Bowel Syndrome, run by Rutgers, The State University of New Jersey at 1 site in Greece.
Trial summary
Chios mastic is a natural product with strong antimicrobial, anti-inflammatory and antioxidant properties, and well-established benefits for dyspeptic disorders. The aim of the present study is to investigate the effectiveness of a natural aqueous extract of Chios mastic (mastic water), a by-product of Chios mastic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Chios mastic water and Chios mastic fruit juice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteGreece
- Study dates
- 12 Sep 2021to 16 May 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old
- Body mass index 18.5-35 kg/m2
- IBS diagnosis
Who cannot join
- Presence of other gastrointestinal disorders, such as gastritis, peptic ulcer, functional dyspepsia, celiac disease and inflammatory bowel disease
- Presence of other serious comorbidities, such as diabetes mellitus, active cancer, cardiovascular disease, pulmonary, kidney, liver, chronic inflammatory, autoimmune or psychiatric diseases
- Recent (within 6 months) surgery or hospitalization
- Habitual excessive alcohol consumption (> 210 or > 140 gr of alcohol per week for men and women, respectively)
- Currently on a weight-loss diet or recent change (within 6 months) in lifestyle habits
- Pregnancy or breast feeding (for women)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University
Kallithea, Attica, 17676
About this study
Official title: The Effectiveness of a Natural Aqueous Extract of Chios Mastic in the Management of Irritable Bowel Syndrome: the MASTIQUA Randomized Controlled Clinical Trial
Chios mastic is a natural product with strong antimicrobial, anti-inflammatory and antioxidant properties, and well-established benefits for dyspeptic disorders. The aim of the present study is to investigate the effectiveness of a natural aqueous extract of Chios mastic (mastic water), a by-product of Chios mastic processing, in the management of irritable bowel syndrome. This will be a 3-month randomized double-blind controlled clinical trial in adult patients with irritable bowel syndrome under standard medication. Participants will be blindly randomized to a low-dose mastic group, which will receive a carbonated water enriched with Chios mastic water (0.06%), a high-dose mastic group, which will receive a carbonated fruit juice enriched with Chios mastic water (0.55%), or one of the two control groups, which will receive an identical placebo water/fruit juice with no active ingredients. Participants will be evaluated in terms of anthropometric indices, lifestyle habits, severity of IBS-related gastrointestinal symptoms, quality of life, as well as biochemical, inflammatory and oxidative stress markers, both pre- and post-intervention.
Read the detailed description
Chios mastic is the resin of the mastic tree (Pistacia Lentiscus var. Chia), produced exclusively in the southern part of the Greek island of Chios. References about its medical use from local populations for the treatment of gastrointestinal disorders or as a cosmetic agent can be found in ancient texts. Nowadays, this versatile resin has been rediscovered, not only as a traditional remedy and aromatic agent, but as a potent phytotherapeutic product with strong anti-inflammatory, anti-microbial and anti-oxidant properties. In 2015, Chios mastic was recognized as a herbal medicinal product by the European Medicines Agency (EMA), with two therapeutic indications: mild dyspeptic disorders and skin inflammation/healing of minor wounds (EMA/HMPC/46758/2015). Over the last years, Chios mastic is widely used in medicinal products, food supplements and cosmetics and has become the object of intense study in the fields of Nutrition and Pharmacotechnology.
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disease characterized by adverse changes in bowel function (frequency of bowel movements and/or stool composition) and abdominal pain. The clinical presentation of IBS usually includes symptoms of abdominal pain, flatulence, bloating, diarrhea and constipation that often alternate, while postprandial discomfort in the upper abdomen, feeling of fullness, nausea, vomiting and back pain are less commonly reported. IBS affects approximately 7-16% of the general population, and leads to reduced functionality and productivity and a significant deterioration in quality of life due to its various intestinal manifestations. The first-line pharmacological treatments for IBS aim at alleviating symptoms and include antispasmodics or anticonvulsants for abdominal pain, antidiarrheal medication and laxatives for constipation. Dietary modifications, such as the avoidance of foods that aggravate gastrointestinal symptoms and various types of exclusion diets, are also applied as adjunctive therapies for IBS management, but evidence of their effectiveness remains scares and inconclusive.
The use of foods/beverages enriched with Chios mastic could constitute a promising complementary approach for the management of IBS, in combination with current first-line pharmacological treatments. The aim of the present interventional study is to explore the effectiveness of a natural aqueous extract of Chios mastic in the management of IBS.
The study will be a 3-month parallel, randomized (allocation ratio 1:1), controlled, double-blind clinical trial in a sample of 60 adult patients with IBS. Eligible participants will be adult (18-65 years old) otherwise healthy individuals with an IBS diagnosis based on ROME IV criteria under stable medication. Participants will be excluded on the basis of the presence of other chronic gastrointestinal diseases, the presence of other serious comorbidities, or recent significant changes in lifestyle habits. Participants will be randomized to a low-dose mastic group (LDMG), a low-dose control group (LDCC), a high-dose mastic group (HDMG) or a high-dose control group (HDCC). The LDMG will be provided with 600 mL of a sparkling water (mastiqua) containing the natural mastic aqueous extract (0.06%) to be consumed daily (3 bottles of 200 mL each). The HDMG will be provided with 600 mL of a sparkling fruit juice (mastiqua lemon) containing the natural mastic aqueous extract (0.55%) to be consumed daily (3 bottles of 200 mL each). The LDCC and HDCC will receive the same quantity of a placebo sparkling water or fruit juice, respectively. For each type of drink (water and fruit juice), the intervention and placebo drinks will be unlabeled and identical in appearance and organoleptic characteristics, including the characteristic Chios mastic aroma. Randomization will be performed by an investigator with no clinical involvement, while all patients and study team members will be blinded to patient allocation in study groups.
All enrolled patients will continue their standard medical treatment which must remain stable throughout the trial. The study physician will systematically record potential side-effects and will be in charge of terminating the intervention if needed. Participants will be assessed in terms of anthropometric indices (body weight, height, waist circumference, and body composition), lifestyle habits (diet and physical activity habits), the presence and severity of gastrointestinal symptoms, and quality of life both pre- and post-intervention. In addition, blood samples after a 12-hour fast and morning urine samples will be collected to measure biochemical, inflammatory and oxidative stress markers.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Chios mastic water, Placebo water, Chios mastic fruit juice, Placebo fruit juice
- Keywords
- Pistacia Lentiscus var. Chia, Chios mastic, mastiha, irritable bowel syndrome, dyspepsia, constipation, diarrhea, abdominal pain, bloating, gastrointestinal health
- Medical subject headings
- Irritable Bowel Syndrome, Dyspepsia, Constipation, Diarrhea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chios mastic waterBehavioural
Also called Mastiqua
Participants randomized to this intervention arm will be provided with a sparkling water enriched with the natural mastic aqueous extract (0.06%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.
Placebo waterBehavioural
Participants randomized to this intervention arm will be provided with a standard sparkling water and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.
Chios mastic fruit juiceBehavioural
Also called Mastiqua lemon
Participants randomized to this intervention arm will be provided with a sparkling fruit juice enriched with the natural mastic aqueous extract (0.55%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.
Placebo fruit juiceBehavioural
Participants randomized to this intervention arm will be provided with a standard sparkling fruit juice and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose mastic group | Experimental | This arm will consume 600 mL of a sparkling water enriched with Chios mastic per day for a 3-month period. Receives: Behavioral: Chios mastic water |
| Low-dose control group | Placebo comparator | This arm will consume 600 mL of a standard sparkling water per day for a 3-month period. Receives: Behavioral: Placebo water |
| High-dose mastic group | Experimental | This arm will consume 600 mL of a sparkling fruit juice enriched with Chios mastic per day for a 3-month period. Receives: Behavioral: Chios mastic fruit juice |
| High-dose control group | Placebo comparator | This arm will consume 600 mL of a standard sparkling fruit juice per day for a 3-month period. Receives: Behavioral: Placebo fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS symptoms severity assessed through the IBS Symptom Severity Scale (IBS-SSS)
The score ranges from 0 to 500, with higher values indicating more severe symptoms.
Measured: 0 (baseline) and 12 weeks
Change in quality of life assessed through the IBS Quality of Life questionnaire (IBS-QOL)
Τhe score ranges from 34 to 170 with higher values indicating lower quality of life.
Measured: 0 (baseline) and 12 weeks
Secondary outcomes (4)
Change in high-sensitivity C-reactive protein
High-sensitivity C-reactive protein (mg/L) will be measured in blood samples by nephelometry.
Measured: 0 (baseline) and 12 weeks
Change in high-sensitivity interleukin-6 levels
High-sensitivity interleukin-6 levels (pg/mL) will be measured in blood samples using commercially available ELISA kits.
Measured: 0 (baseline) and 12 weeks
Change in malondialdehyde
Malondialdehyde levels (nmol/mL) will be measured in blood samples through HPLC-Fluorescence.
Measured: 0 (baseline) and 12 weeks
Change in total serum antioxidant capacity
Total serum antioxidant capacity (μmol/L) will be measured in blood samples using commercially available ELISA kits.
Measured: 0 (baseline) and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start12 Sep 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University
- Responsible party
- Principal investigator, Labros Sidossis, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Labros Sidossis, PhD, Principal investigator, Department of Kinesiology and Health, School of Arts and Sciences, Rutgers UniversityMichael Georgoulis, PhD, Study chair, Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio UniversityAlexandra Karachaliou, MSc, Study chair, Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893499
- Sponsor's protocol ID
- Γ-1038/12-3-2021
- Acronym
- MASTIQUA
- Status last verified
- Sep 2022
- First submitted
- 14 May 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be shared to investigators for the purpose of data meta-analysis, provided that the proposed use of the data has been approved by the Study Principal Investigator. Proposals should be directed to lsidossis@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Natural Aqueous Extract of Chios Mastic in the Management of Irritable Bowel Syndrome: the MASTIQUA Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04893499
- Acronym / sponsor ID
- MASTIQUA / Γ-1038/12-3-2021
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Pistacia Lentiscus var. Chia, Chios mastic, mastiha, irritable bowel syndrome, dyspepsia, constipation, diarrhea, abdominal pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Harokopio University
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 19 May 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.
Chios mastic is a natural product with strong antimicrobial, anti-inflammatory and antioxidant properties, and well-established benefits for dyspeptic disorders. The aim of the present study is to investigate the effectiveness of a natural aqueous extract of Chios mastic (mastic water), a by-product of Chios mastic processing, in the management of irritable bowel syndrome. This will be a 3-month randomized double-blind controlled clinical trial in adult patients with irritable bowel syndrome under standard medication. Participants will be blindly randomized to a low-dose mastic group, which will receive a carbonated water enriched with Chios mastic water (0.06%), a high-dose mastic group, which will receive a carbonated fruit juice enriched with Chios mastic water (0.55%), or one of the two control groups, which will receive an identical placebo water/fruit juice with no active ingredients. Participants will be evaluated in terms of anthropometric indices, lifestyle habits, severity of IBS-related gastrointestinal symptoms, quality of life, as well as biochemical, inflammatory and oxidative stress markers, both pre- and post-intervention.
Detailed description
Chios mastic is the resin of the mastic tree (Pistacia Lentiscus var. Chia), produced exclusively in the southern part of the Greek island of Chios. References about its medical use from local populations for the treatment of gastrointestinal disorders or as a cosmetic agent can be found in ancient texts. Nowadays, this versatile resin has been rediscovered, not only as a traditional remedy and aromatic agent, but as a potent phytotherapeutic product with strong anti-inflammatory, anti-microbial and anti-oxidant properties. In 2015, Chios mastic was recognized as a herbal medicinal product by the European Medicines Agency (EMA), with two therapeutic indications: mild dyspeptic disorders and skin inflammation/healing of minor wounds (EMA/HMPC/46758/2015). Over the last years, Chios mastic is widely used in medicinal products, food supplements and cosmetics and has become the object of intense study in the fields of Nutrition and Pharmacotechnology.
Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disease characterized by adverse changes in bowel function (frequency of bowel movements and/or stool composition) and abdominal pain. The clinical presentation of IBS usually includes symptoms of abdominal pain, flatulence, bloating, diarrhea and constipation that often alternate, while postprandial discomfort in the upper abdomen, feeling of fullness, nausea, vomiting and back pain are less commonly reported. IBS affects approximately 7-16% of the general population, and leads to reduced functionality and productivity and a significant deterioration in quality of life due to its various intestinal manifestations. The first-line pharmacological treatments for IBS aim at alleviating symptoms and include antispasmodics or anticonvulsants for abdominal pain, antidiarrheal medication and laxatives for constipation. Dietary modifications, such as the avoidance of foods that aggravate gastrointestinal symptoms and various types of exclusion diets, are also applied as adjunctive therapies for IBS management, but evidence of their effectiveness remains scares and inconclusive.
The use of foods/beverages enriched with Chios mastic could constitute a promising complementary approach for the management of IBS, in combination with current first-line pharmacological treatments. The aim of the present interventional study is to explore the effectiveness of a natural aqueous extract of Chios mastic in the management of IBS.
The study will be a 3-month parallel, randomized (allocation ratio 1:1), controlled, double-blind clinical trial in a sample of 60 adult patients with IBS. Eligible participants will be adult (18-65 years old) otherwise healthy individuals with an IBS diagnosis based on ROME IV criteria under stable medication. Participants will be excluded on the basis of the presence of other chronic gastrointestinal diseases, the presence of other serious comorbidities, or recent significant changes in lifestyle habits. Participants will be randomized to a low-dose mastic group (LDMG), a low-dose control group (LDCC), a high-dose mastic group (HDMG) or a high-dose control group (HDCC). The LDMG will be provided with 600 mL of a sparkling water (mastiqua) containing the natural mastic aqueous extract (0.06%) to be consumed daily (3 bottles of 200 mL each). The HDMG will be provided with 600 mL of a sparkling fruit juice (mastiqua lemon) containing the natural mastic aqueous extract (0.55%) to be consumed daily (3 bottles of 200 mL each). The LDCC and HDCC will receive the same quantity of a placebo sparkling water or fruit juice, respectively. For each type of drink (water and fruit juice), the intervention and placebo drinks will be unlabeled and identical in appearance and organoleptic characteristics, including the characteristic Chios mastic aroma. Randomization will be performed by an investigator with no clinical involvement, while all patients and study team members will be blinded to patient allocation in study groups.
All enrolled patients will continue their standard medical treatment which must remain stable throughout the trial. The study physician will systematically record potential side-effects and will be in charge of terminating the intervention if needed. Participants will be assessed in terms of anthropometric indices (body weight, height, waist circumference, and body composition), lifestyle habits (diet and physical activity habits), the presence and severity of gastrointestinal symptoms, and quality of life both pre- and post-intervention. In addition, blood samples after a 12-hour fast and morning urine samples will be collected to measure biochemical, inflammatory and oxidative stress markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose mastic group | Experimental | Behavioral: Chios mastic waterThis arm will consume 600 mL of a sparkling water enriched with Chios mastic per day for a 3-month period. |
| Low-dose control group | Placebo comparator | Behavioral: Placebo waterThis arm will consume 600 mL of a standard sparkling water per day for a 3-month period. |
| High-dose mastic group | Experimental | Behavioral: Chios mastic fruit juiceThis arm will consume 600 mL of a sparkling fruit juice enriched with Chios mastic per day for a 3-month period. |
| High-dose control group | Placebo comparator | Behavioral: Placebo fruit juiceThis arm will consume 600 mL of a standard sparkling fruit juice per day for a 3-month period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old
- Body mass index 18.5-35 kg/m2
- IBS diagnosis
Key exclusion criteria (6 listed)
- Presence of other gastrointestinal disorders, such as gastritis, peptic ulcer, functional dyspepsia, celiac disease and inflammatory bowel disease
- Presence of other serious comorbidities, such as diabetes mellitus, active cancer, cardiovascular disease, pulmonary, kidney, liver, chronic inflammatory, autoimmune or psychiatric diseases
- Recent (within 6 months) surgery or hospitalization
- Habitual excessive alcohol consumption (> 210 or > 140 gr of alcohol per week for men and women, respectively)
- Currently on a weight-loss diet or recent change (within 6 months) in lifestyle habits
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 |
|---|---|---|
| Chios mastic waterAlso: MastiquaParticipants randomized to this intervention arm will be provided with a sparkling water enriched with the natural mastic aqueous extract (0.06%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study. | Behavioural | Low-dose mastic group |
| Placebo waterParticipants randomized to this intervention arm will be provided with a standard sparkling water and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study. | Behavioural | Low-dose control group |
| Chios mastic fruit juiceAlso: Mastiqua lemonParticipants randomized to this intervention arm will be provided with a sparkling fruit juice enriched with the natural mastic aqueous extract (0.55%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study. | Behavioural | High-dose mastic group |
| Placebo fruit juiceParticipants randomized to this intervention arm will be provided with a standard sparkling fruit juice and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study. | Behavioural | High-dose control group |
Primary outcome
Change in IBS symptoms severity assessed through the IBS Symptom Severity Scale (IBS-SSS)
Time frame: 0 (baseline) and 12 weeks
The score ranges from 0 to 500, with higher values indicating more severe symptoms.
Change in quality of life assessed through the IBS Quality of Life questionnaire (IBS-QOL)
Time frame: 0 (baseline) and 12 weeks
Τhe score ranges from 34 to 170 with higher values indicating lower quality of life.
4 secondary outcomes
Change in high-sensitivity C-reactive protein
Time frame: 0 (baseline) and 12 weeks
Change in high-sensitivity interleukin-6 levels
Time frame: 0 (baseline) and 12 weeks
Change in malondialdehyde
Time frame: 0 (baseline) and 12 weeks
Change in total serum antioxidant capacity
Time frame: 0 (baseline) and 12 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 29 Sep 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be shared to investigators for the purpose of data meta-analysis, provided that the proposed use of the data has been approved by the Study Principal Investigator. Proposals should be directed to lsidossis@gmail.com. To gain access, data requestors will need to sign a data access agreement.
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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.
Labros Sidossis, PhD principal investigator
Department of Kinesiology and Health, School of Arts and Sciences, Rutgers University
Michael Georgoulis, PhD study chair
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University
Alexandra Karachaliou, MSc study chair
Department of Nutrition and Dietetics, School of Health Sciences and Education, Harokopio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chios mastic water and Chios mastic fruit juice in people with Irritable Bowel Syndrome, run by Rutgers, The State University of New Jersey at 1 site in Greece.
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 3 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 Sep 2022. 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 Greece. 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 IBS symptoms severity assessed through the IBS Symptom Severity Scale (IBS-SSS) (time frame: 0 (baseline) and 12 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?
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 Sep 2022.