Irritable Bowel SyndromeNCT07103772
Effect of Consuming a Nutraceutical Composition on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
A study testing Ananá in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Irritable bowel syndrome is characterized by the presence of chronic, recurrent abdominal pain, alterations in bowel habits, and abdominal distension. The medical diagnosis is made using the Rome IV criteria. There are three IBS phenotypes: diarrhea-predominant, constipation-predominant, and mixed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation
- What is being tested?
- Ananá
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteMexico
- Study dates
- 14 Mar 2024to 15 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be over 18 years old.
- Be an employee or beneficiary of UANL.
- Have gastrointestinal alterations (diarrhea, constipation, etc.) that suggest the presence of irritable bowel syndrome.
- Not be under any medical treatment.
Who cannot join
- Being under medical treatment.
- Not having gastrointestinal alterations much as diarrhea, constipation, etc.
- being under 18 years old.
- Not being an employee or beneficiary of UANL.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: Effect of Consuming a Nutraceutical Composition Based on Pineapple and Natural Extracts on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
Irritable bowel syndrome is characterized by the presence of chronic, recurrent abdominal pain, alterations in bowel habits, and abdominal distension. The medical diagnosis is made using the Rome IV criteria. There are three IBS phenotypes: diarrhea-predominant, constipation-predominant, and mixed.
Read the detailed description
A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Being tested
- Ananá
- Keywords
- Síndrome del intestino irritable, Piña, Nuez, Guayaba, Intestino, Suplemento dietético, Antiinflamación, Efecto digestivo, Digestión
- 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.
AnanáDietary supplement
The supplement consists of a box containing 14 sachets of the product for 14 days of treatment. Patients should preferably consume the supplement in the morning.
The "Ananá's Nutraceutical Group" will receive the real supplement for consumption over 14 days, while the "Ananá's Placebo Group" will receive a placebo supplement for comparison at the end of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Ananá´s Nutraceutical Goup | Experimental | 47 personas recibirán el tratamiento de 14 días con el suplemento nutracéutico. Receives: Dietary Supplement: Ananá |
| Ananá´s Placebo Group | Placebo comparator | 47 people will recieve the 14 day treatment with the placebo supplement. Receives: Dietary Supplement: Ananá |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome.
A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start14 Mar 2024
- Primary completion14 Mar 2025
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between two groups: nutraceutical and placebo treatment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adbel Zaid Martínez Baez, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103772
- Sponsor's protocol ID
- 23-FaSPyN-AG-06
- Status last verified
- Aug 2025
- First submitted
- 10 Feb 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The personal data, including biochemical data of the participants, will not be shared for use in other clinical trials or for additional research purposes.
Publications
Menees SB, Powell C, Kurlander J, Goel A, Chey WD. A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. Am J Gastroenterol. 2015 Mar;110(3):444-54. doi: 10.1038/ajg.2015.6. Epub 2015 Mar 3.
PubMed 25732419Kansakar U, Trimarco V, Manzi MV, Cervi E, Mone P, Santulli G. Exploring the Therapeutic Potential of Bromelain: Applications, Benefits, and Mechanisms. Nutrients. 2024 Jun 28;16(13):2060. doi: 10.3390/nu16132060.
PubMed 38999808Liu YM, Lin IJ, Huang CW, Chien RC, Mau CZ, Mau JL. Effect of Ethanolic Extracts from Taiwanofungus camphoratus and T. salmoneus (Agaricomycetes) Mycelia on Osteoporosis Recovery. Int J Med Mushrooms. 2020;22(3):277-287. doi: 10.1615/IntJMedMushrooms.2020033983.
PubMed 32479022Dai K, Agarwal N, Rodriguez-Palacios A, Basson AR. Regulation of Intestinal Inflammation by Walnut-Derived Bioactive Compounds. Nutrients. 2024 Aug 10;16(16):2643. doi: 10.3390/nu16162643.
PubMed 39203780Borrelli F, Capasso R, Severino B, Fiorino F, Aviello G, De Rosa G, Mazzella M, Romano B, Capasso F, Fasolino I, Izzo AA. Inhibitory effects of bromelain, a cysteine protease derived from pineapple stem (Ananas comosus), on intestinal motility in mice. Neurogastroenterol Motil. 2011 Aug;23(8):745-e331. doi: 10.1111/j.1365-2982.2011.01735.x. Epub 2011 Jun 21.
PubMed 21689210Ballou S, Singh P, Nee J, Rangan V, Iturrino J, Geeganage G, Lowe B, Bangdiwala SI, Palsson OS, Sperber AD, Lembo A, Lehmann M. Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology. 2023 Sep;165(3):647-655.e4. doi: 10.1053/j.gastro.2023.05.049. Epub 2023 Jun 13.
PubMed 37315866Bakare AO, Owoyele BV. Bromelain reduced pro-inflammatory mediators as a common pathway that mediate antinociceptive and anti-anxiety effects in sciatic nerve ligated Wistar rats. Sci Rep. 2021 Jan 11;11(1):289. doi: 10.1038/s41598-020-79421-9.
PubMed 33432004Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.
PubMed 32702295
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming a Nutraceutical Composition Based on Pineapple and Natural Extracts on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07103772
- Acronym / sponsor ID
- 23-FaSPyN-AG-06
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Keywords
- Síndrome del intestino irritable, Piña, Nuez, Guayaba, Intestino, Suplemento dietético, Antiinflamación, Efecto digestivo
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 5 Aug 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.
Irritable bowel syndrome is characterized by the presence of chronic, recurrent abdominal pain, alterations in bowel habits, and abdominal distension. The medical diagnosis is made using the Rome IV criteria. There are three IBS phenotypes: diarrhea-predominant, constipation-predominant, and mixed.
Detailed description
A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Comparison between two groups: nutraceutical and placebo treatment.
| Arm | Type | Receives |
|---|---|---|
| Ananá´s Nutraceutical Goup | Experimental | Dietary Supplement: Ananá47 personas recibirán el tratamiento de 14 días con el suplemento nutracéutico. |
| Ananá´s Placebo Group | Placebo comparator | Dietary Supplement: Ananá47 people will recieve the 14 day treatment with the placebo supplement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be over 18 years old.
- Be an employee or beneficiary of UANL.
- Have gastrointestinal alterations (diarrhea, constipation, etc.) that suggest the presence of irritable bowel syndrome.
- Not be under any medical treatment.
Key exclusion criteria (4 listed)
- Being under medical treatment.
- Not having gastrointestinal alterations much as diarrhea, constipation, etc.
- being under 18 years old.
- Not being an employee or beneficiary of UANL.
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 |
|---|---|---|
| AnanáThe supplement consists of a box containing 14 sachets of the product for 14 days of treatment. Patients should preferably consume the supplement in the morning. The "Ananá's Nutraceutical Group" will receive the real supplement for consumption over 14 days, while the "Ananá's Placebo Group" will receive a placebo supplement for comparison at the end of the trial. | Dietary supplement | Ananá´s Nutraceutical Goup, Ananá´s Placebo Group |
Primary outcome
Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome.
Time frame: 1 year
A sample of 100 people will be supplemented, with 50 participants consuming the nutraceutical gel and the remaining 50 receiving a placebo supplement. The supplementation period lasts 14 days, during which severity questionnaires and the Bristol Stool Scale will be administered on Day 0, Day 7, and Day 14. Additionally, to assess biomarkers, biochemical tests for PCR, calprotectin, and fecal lactoferrin will be conducted.
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 2 Sep 2025.
- Background: PubMed 25732419Menees SB, Powell C, Kurlander J, Goel A, Chey WD. A meta-analysis of the utility of C-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. Am J Gastroenterol. 2015 Mar;110(3):444-54. doi: 10.1038/ajg.2015.6. Epub 2015 Mar 3.
- Background: PubMed 38999808Kansakar U, Trimarco V, Manzi MV, Cervi E, Mone P, Santulli G. Exploring the Therapeutic Potential of Bromelain: Applications, Benefits, and Mechanisms. Nutrients. 2024 Jun 28;16(13):2060. doi: 10.3390/nu16132060.
- Background: PubMed 32479022Liu YM, Lin IJ, Huang CW, Chien RC, Mau CZ, Mau JL. Effect of Ethanolic Extracts from Taiwanofungus camphoratus and T. salmoneus (Agaricomycetes) Mycelia on Osteoporosis Recovery. Int J Med Mushrooms. 2020;22(3):277-287. doi: 10.1615/IntJMedMushrooms.2020033983.
- Background: PubMed 39203780Dai K, Agarwal N, Rodriguez-Palacios A, Basson AR. Regulation of Intestinal Inflammation by Walnut-Derived Bioactive Compounds. Nutrients. 2024 Aug 10;16(16):2643. doi: 10.3390/nu16162643.
- Background: PubMed 21689210Borrelli F, Capasso R, Severino B, Fiorino F, Aviello G, De Rosa G, Mazzella M, Romano B, Capasso F, Fasolino I, Izzo AA. Inhibitory effects of bromelain, a cysteine protease derived from pineapple stem (Ananas comosus), on intestinal motility in mice. Neurogastroenterol Motil. 2011 Aug;23(8):745-e331. doi: 10.1111/j.1365-2982.2011.01735.x. Epub 2011 Jun 21.
- Background: PubMed 37315866Ballou S, Singh P, Nee J, Rangan V, Iturrino J, Geeganage G, Lowe B, Bangdiwala SI, Palsson OS, Sperber AD, Lembo A, Lehmann M. Prevalence and Associated Factors of Bloating: Results From the Rome Foundation Global Epidemiology Study. Gastroenterology. 2023 Sep;165(3):647-655.e4. doi: 10.1053/j.gastro.2023.05.049. Epub 2023 Jun 13.
- Background: PubMed 33432004Bakare AO, Owoyele BV. Bromelain reduced pro-inflammatory mediators as a common pathway that mediate antinociceptive and anti-anxiety effects in sciatic nerve ligated Wistar rats. Sci Rep. 2021 Jan 11;11(1):289. doi: 10.1038/s41598-020-79421-9.
- Background: PubMed 32702295Oka P, Parr H, Barberio B, Black CJ, Savarino EV, Ford AC. Global prevalence of irritable bowel syndrome according to Rome III or IV criteria: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):908-917. doi: 10.1016/S2468-1253(20)30217-X. Epub 2020 Jul 20.
- Individual participant dataSharing planned: No. The personal data, including biochemical data of the participants, will not be shared for use in other clinical trials or for additional research purposes.
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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.
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 Ananá in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 4 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: enrolling by invitation, as of the sponsor's last update on 2 Sep 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 Mexico. 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?
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?
Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome. (time frame: 1 year). 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 NCT07103772, which also lists 8 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 2 Sep 2025.