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Irritable bowel syndrome symptom severity improves equally with probiotic and placebo
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AIM: NCFM on irritable bowel syndrome (IBS) symptoms and quality of life (QoL). METHODS: colony-forming units of NCFM or placebo daily for 12 wk. IBS Symptom Severity Score (IBS-SSS), which constituted the primary outcome, and secondary outcomes, including individual IBS symptoms, IBS-related QoL questionnaire, anxiety and depression, defecation frequency, and stool consistency, were assessed at baseline at the end of the 8-wk run-in period, after 4 and 12 wk of intervention, and after a 4-wk washout. RESULTS: combined active doses = 0.0460). CONCLUSION: NCFM alleviates moderate to severe abdominal pain, consistent with earlier observations of this strain mitigating visceral pain through increased analgesic receptor expression.
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![Figure 1 Study outline. Volunteers were selected for screening visits by a prescreen for compliance over the phone. Eligible volunteers entered an 8-wk run-in period without any investigational product (IP) consumption and were thereafter randomized to receive low- or high-dose active IP or a placebo IP for 12 wk. The intervention period was followed by a 4-wk washout period without any IP consumption. Preceding each time point (weeks 0, 4, 12, and 16), volunteers recorded their stool consistency during each defecation event for 7 d. At each time point, questionnaires [Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS); IBS-related Quality of Life (IBS-QoL); Hospital Anxiety and Depression Score (HADS)] were filled out. All volunteers were contacted by phone prior to each sampling time point to inquire about adverse events (AEs) and to remind of the sampling procedures.](/paper-figures/185a9a254005472cab8cb915b6531c65/irritable-bowel-syndrome-symptom-severity-improves-equally-with-probiotic-and-figure-1.jpg)

![Figure 3 Irritable bowel syndrome symptom severity score over time. IBS-SSS is a 5-item composite score inquiring about the severity of abdominal pain, bloating/distension, satisfaction with bowel habits, and IBS-related quality of life on a 10-cm VAS scale and the number of days with abdominal pain over the past 10 d[18]. All items are scored from 0 to 100, allowing for IBS-SSSs to range from 0 to 500. Francis and colleagues have validated non-IBS controls and volunteers suffering from mild, moderate, and severe IBS symptoms to range between 0-75, 75-175, 175-300, and 300-500, respectively[18]. The composite symptom score declined similarly in all treatment groups during the intervention, showing no treatment effect for the active groups (low-dose and high-dose) receiving Lactobacillus acidophilus NCFM. The severity scores are given as mean ± SD. Differences from baseline to week 12 were not significant between treatment groups. All within-group comparisons to baseline (week 4, week 12, and washout) were significant (P < 0.001). IBS-SSS: Irritable bowel syndrome symptom severity score; IBS: Irritable bowel syndrome.](/paper-figures/322519e6415e41eea9ed2f3fccc3f7f9/irritable-bowel-syndrome-symptom-severity-improves-equally-with-probiotic-and-figure-3.jpg)
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“Based on the international consensus and existing evidence, probiotics are beneficial in improving overall symptoms in patients with IBS [29,30,31,32,33,34,35], but there are still contradictory reports on improvements in specific symptoms [36,37,38].”
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Metadata
- Authors
- Lyra, A., Hillilä, M., Huttunen, T., Männikkö, S., Taalikka, M., Tennilä, J., Tarpila, A., Lahtinen, S., Ouwehand, A. C., & Veijola, L.
- Affiliations
- DuPont (Finland) (FI)
- Venue
- World Journal of Gastroenterology
- Publisher
- Baishideng Publishing Group Inc.
- Published
- 2016
- Volume
- 22
- Issue
- 48
- Pages
- 10631
- ISSN
- 1007-9327 (ISSN-L)
- PMC
- PMC5192275
- OpenAlex
- W2560913755
- Cited by
- 106
- References
- 35
- Citations by year
- 2026: 5 · 2025: 8 · 2024: 11 · 2023: 16 · 2022: 15 · 2021: 17 · 2020: 14 · 2019: 8 · 2018: 10 · 2017: 1 · 2016: 1
- FWCI
- 7.30
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- World Journal of Gastroenterology (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Työväentutkimus Vuosikirja (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- irritable bowel syndrome, probiotics, placebo, symptom severity, quality of life, abdominal pain, anxiety, depression, stool frequency, stool consistency, visceral pain
- MeSH terms
- Adult, Colon, Dose-Response Relationship, Drug, Female, Humans, Intestinal Mucosa, Lactobacillus acidophilus, Male, Middle Aged, Pain Measurement, Surveys and Questionnaires, Receptors, Opioid, Severity of Illness Index, Abdominal Pain, Treatment Outcome, Probiotics, Irritable Bowel Syndrome, Visceral Pain
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