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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ananá´s Nutraceutical Goup | Experimental | 47 personas recibirán el tratamiento de 14 días con el suplemento nutracéutico. |
|
| Ananá´s Placebo Group | Placebo Comparator | 47 people will recieve the 14 day treatment with the placebo supplement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male or female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25732419 | Background | 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. | |
| 38999808 |
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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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Comparison between two groups: nutraceutical and placebo treatment.
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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.
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| 21689210 | 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. |
| 37315866 | 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. |
| 33432004 | 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. |
| 32702295 | 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. |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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