CRN Digestive Discomfort
Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.
To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.
The following protocols were developed using only A through D-quality evidence.
Introduction
Irritable bowel syndrome (IBS) is a common chronic digestive disorder characterized by recurrent abdominal pain and bowel habit changes. Prevalence of IBS is on the rise in the United States, with recent estimates reporting that 6.1% adults struggle with the condition. IBS is a clinical and public health concern because it substantially diminishes quality of life and contributes to work absenteeism, reduced productivity, and considerable healthcare costs. (Dean 2005)(Tetali 2024)
These burdens on quality of life and healthcare systems, coupled with high rates of patient-reported treatment dissatisfaction, highlight the need for accessible and evidence-based approaches that can be integrated into routine clinical care. (Lacy 2024) This protocol summarizes the findings of the Council for Responsible Nutrition’s (CRN’s) Supplements to Savings report to provide a starting foundation for such an approach.
Ingredients
Probiotics
Dosing: At least one billion colony-forming units (CFU) per day, minimum of four weeks (Zhang 2023)
Supporting evidence:
- A systematic review and meta-analysis of 43 randomized controlled trials (RCTs) concluded that probiotics effectively improve IBS symptoms; however, no definite conclusions could be drawn on the optimal species and strains. Over 20% more people taking probiotics reported relief of global IBS symptoms, abdominal pain, bloating, and flatulence than those taking a placebo. (Ford 2014)
- According to this more recent systematic review and meta-analysis, probiotics are effective and safe for treating IBS and are correlated with a significant improvement in global IBS symptoms and quality of life compared to placebo. The analysis of 20 studies (3,011 patients) concluded that high-dose probiotics (>10 billion CFU per day) and multi-strain formulations were associated with greater benefit, particularly for abdominal pain and distension. (Yang 2024)
- In a randomized triple-blind placebo-controlled trial, patients with IBS (n=340) took either one billion or ten billion CFU of Lactobacillus acidophilus NCFM or a placebo daily for 12 weeks. While there were no significant differences in IBS symptom severity scores (IBS-SSS) at the end of the trial between the three groups, a post-hoc analysis did reveal that probiotics at either dose effectively reduced moderate-to-severe abdominal pain compared to the placebo. Pain scores fell by 20.8 ± 22.8, 29.4 ± 17.9, and 31.2 ± 21.9 in the placebo, active low-dose, and active high-dose groups, respectively. (Lyra 2016)
- In this multicenter RCT, 362 patients with IBS were randomized to receive a placebo or encapsulated Bifidobacterium infantis 35624 at a dose of one million, 100 million, or 10 billion CFU per day for four weeks. B. infantis at a dose of 100 million CFU per day was significantly superior to placebo and all other probiotic doses for relieving abdominal pain, bloating, bowel dysfunction, incomplete evacuation, straining, and gas, with improvement in global symptom assessment exceeding placebo by more than 20%. (Whorwell 2006)
- A probiotic mixture containing Lactobacillus rhamnosus GG, L. rhamnosus LC705, B. breve Bb99, and Propionibacterium freudenreichii ssp. shermanii JS (8–9 billion CFU daily with equal amounts of each strain), reduced the total IBS symptom score—covering abdominal pain, distension, flatulence, and borborygmus—by 42% after six months, compared with only a 6% reduction in the placebo group. The trial included 103 patients who met Rome I or II diagnostic criteria for IBS. (Kajander 2005)
- Female patients with diarrhea-predominant IBS (IBS-D) and constipation-predominant IBS (IBS-C) (n=113) experienced improvements in quality of life, as well as stool frequency and consistency, after 12 weeks of daily probiotic therapy. The intervention provided 50 billion CFU daily, consisting of live Lactobacillus acidophilus CL1285, L. casei LBC80R, and L. rhamnosus CLR2. (Preston 2018)
Probiotics in the Fullscript catalog
Disclaimer
The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.
- Dean, B. B., Aguilar, D., Barghout, V., et al. (2005). Impairment in work productivity and health-related quality of life in patients with IBS. The American Journal of Managed Care, 11(1 Suppl), S17-26. https://pubmed.ncbi.nlm.nih.gov/15926760/
- Ford, A. C., Quigley, E. M. M., Lacy, B. E., et al. (2014). Efficacy of Prebiotics, Probiotics, and Synbiotics in Irritable Bowel Syndrome and Chronic Idiopathic Constipation: Systematic Review and Meta-analysis. American Journal of Gastroenterology, 109(10), 1547–1561. https://doi.org/10.1038/ajg.2014.202
- Kajander, K., Hatakka, K., Poussa, T., et al. (2005). A probiotic mixture alleviates symptoms in irritable bowel syndrome patients: a controlled 6-month intervention. Alimentary Pharmacology and Therapeutics, 22(5), 387–394. https://doi.org/10.1111/j.1365-2036.2005.02579.x
- Lacy, B. E., Xu, Y., Taylor, D. C. A., et al. (2024). Burden of illness and treatment attitudes among participants meeting Rome IV criteria for irritable bowel syndrome: A nationwide survey in the United States. Neurogastroenterology & Motility, 36(11), e14903. https://doi.org/10.1111/nmo.14903
- Lyra, A., Hillilä, M., Huttunen, T., et al. (2016). Irritable bowel syndrome symptom severity improves equally with probiotic and placebo. World Journal of Gastroenterology, 22(48), 10631–10642. https://doi.org/10.3748/wjg.v22.i48.10631
- Preston, K., Krumian, R., Hattner, J., et al. (2018). Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 improve quality-of-life and IBS symptoms: a double-blind, randomised, placebo-controlled study. Beneficial Microbes, 9(5), 697–706. https://doi.org/10.3920/bm2017.0105
- Tetali, B., & Suresh, S. (2024). Management of irritable bowel syndrome: A narrative review. Translational Gastroenterology and Hepatology, 9, 26. https://doi.org/10.21037/tgh-23-96
- Whorwell, P. J., Altringer, L., Morel, J., et al. (2006). Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome. The American Journal of Gastroenterology, 101(7), 1581–1590. https://doi.org/10.1111/j.1572-0241.2006.00734.x
- Yang, R., Jiang, J., Ouyang, J., et al. (2024). Efficacy and safety of probiotics in irritable bowel syndrome: A systematic review and meta-analysis. Clinical Nutrition ESPEN, 60, 362–372. https://doi.org/10.1016/j.clnesp.2024.02.025
- Zhang, W. X., Shi, L. B., Zhou, M. S., et al. (2023). Efficacy of probiotics, prebiotics and synbiotics in irritable bowel syndrome: a systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials. Journal of Medical Microbiology/Journal of Medical Microbiology, 72(9). https://doi.org/10.1099/jmm.0.001758