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

NCT07103772 | Enrolling By Invitation DMC

• 1 other identifier: 23-FaSPyN-AG-06
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

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; Digestión

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Ananá´s Nutraceutical Goup

EXPERIMENTAL

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

Dietary Supplement: Ananá

Ananá´s Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Ananá

Interventions

Ananá 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 Nutraceutical Goup; Ananá´s Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male or female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (8)

• 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.

  PMID: 25732419 BACKGROUND

• 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.

  PMID: 38999808 BACKGROUND

• 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.

  PMID: 32479022 BACKGROUND

• 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.

  PMID: 39203780 BACKGROUND

• 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.

  PMID: 21689210 BACKGROUND

• 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.

  PMID: 37315866 BACKGROUND

• 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.

  PMID: 33432004 BACKGROUND

• 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.

  PMID: 32702295 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sciences' Doctor

Model Details: Comparison between two groups: nutraceutical and placebo treatment.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: August 5, 2025
• Study Start: March 14, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 15, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)