Effect of Consuming a Nutraceutical Composition on Signs and Symptoms in Adult Patients With Irritable Bowel Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ananá.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Dietary supplement 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.
Primary outcome measures
- Effect of the Consumption of a Nutraceutical Composition on Signs and Symptoms in Adult Patients with Irritable Bowel Syndrome. [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Hospital Universitario Dr. Jose Eleuterio Gonzalez — Monterrey
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. PMID 25732419
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07103772 · 23-FaSPyN-AG-06