Effect of Consuming a Nutraceutical Composition on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome

NCT ID: NCT07103772

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-14

Study Completion Date

2026-03-15

Brief Summary

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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

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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

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Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Irritable Bowel Syndrome With Constipation Irritable Bowel Syndrome Mixed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Comparison between two groups: nutraceutical and placebo treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
For the purposes of the study, it was decided to use a double-blind method, where neither the investigator nor the patient knows which treatment is the nutraceutical and which is the placebo. To achieve this, the team was responsible for mixing the treatment packages to allow for proper distribution.

Study Groups

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Ananá´s Nutraceutical Goup

47 personas recibirán el tratamiento de 14 días con el suplemento nutracéutico.

Group Type EXPERIMENTAL

Ananá

Intervention Type DIETARY_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.

Ananá´s Placebo Group

47 people will recieve the 14 day treatment with the placebo supplement.

Group Type PLACEBO_COMPARATOR

Ananá

Intervention Type DIETARY_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.

Interventions

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Ananá

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Adbel Zaid Martínez Baez

Sciences' Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 25732419 (View on PubMed)

Kansakar 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.

Reference Type BACKGROUND
PMID: 38999808 (View on PubMed)

Liu 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.

Reference Type BACKGROUND
PMID: 32479022 (View on PubMed)

Dai 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.

Reference Type BACKGROUND
PMID: 39203780 (View on PubMed)

Borrelli 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.

Reference Type BACKGROUND
PMID: 21689210 (View on PubMed)

Ballou 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.

Reference Type BACKGROUND
PMID: 37315866 (View on PubMed)

Bakare 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.

Reference Type BACKGROUND
PMID: 33432004 (View on PubMed)

Oka 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.

Reference Type BACKGROUND
PMID: 32702295 (View on PubMed)

Other Identifiers

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23-FaSPyN-AG-06

Identifier Type: -

Identifier Source: org_study_id

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