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 C-quality evidence.

Class
Qualifying studies
Minimum requirements
A
Systematic review or meta-analysis of human trials
 
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study

Healthy bowel movements are essential for gastrointestinal integrity. Acute cases of stools that are too loose, unformed, or liquid can be potentially life-threatening depending on the root cause. According to the Global Burden of Diseases, Injuries, and Risk Factors Study in 2016, diarrhea was the eighth leading cause of death for all ages, while it was the fifth leading cause in children under the age of 5. (7) While diarrhea may be caused by different factors, sanitation, and poor water are the most common causes. (7)

Other possible causes of diarrhea can be attributed to traveling or antibiotic use. In these cases, treatment can be planned accordingly to help lessen the burden. Chronic cases can affect up to 5% of the population. (19) Anywhere from 3% to 17% of patients who had traveler’s diarrhea may experience residual chronic issues with irritable bowel syndrome. (20

The protocol below presents ingredients to help in both the prevention and management of loose stools and/or diarrhea.

Probiotics

2-8 billion CFU, total per day, minimum 3 months (10)(14

  • Probiotics have been shown to decrease diarrhea in conditions like traveler’s diarrhea and antibiotic-associated diarrhea (1)(15)(8)  
  • Bacillus coagulans decreased stool frequency in diarrhea-associated irritable bowel syndrome (IBS-D) (14)  
  • A blend of probiotics including Lactobacillus acidophilus and Bifidobacterium bifidum, has shown to decrease daily stool frequency (10)(17
  • Patients with moderate to severe symptomatic diarrhea-predominant IBS (IBS-D) experienced improved quality of life (QOL), decreased IBS severity scoring system by 145 points from baseline, decreased severity of abdominal pain by 69% (compared to 47% in placebo) and lowered proportion of patients with symptoms to 14% (compared to 48% in placebo) when given multi-strain probiotic Bio-Kult® for 16 weeks (10
  • When given 2 billion CFU per day of single strain probiotic of B. coagulans MTCC 5856 for 90 days, quality of life, disease severity, and symptoms in patients with IBS-D all improved as shown by a decrease in bloating, vomiting, diarrhea, abdominal pain and stool frequency when compared to placebo (14)
  • In a meta-analysis of travelers diarrhea, probiotics were found to be beneficial as a preventative measure (1)
  • Meta-analysis of probiotic S. boulardii was found to be efficacious and safe in treatment of several types of diarrhea, particularly in antibiotic associated diarrhea (15)
  • Systematic review and meta-analysis of 82 randomized controlled trials found that the majority of studies used single strain and multi-strain probiotics containing lactobacillus based formulas which decreased occurrences of antibiotic associated diarrhea (8)
Probiotics in the Fullscript catalog

Prebiotics

5.5 g, total per day, minimum 1 week (4)(9

  • Galacto-oligosaccharide was shown to prevent the incidence of traveler’s diarrhea (4
  • Prebiotics, specifically oligofructose, were shown to reduce relapse of diarrhea in C-difficile patients (11)
  • Prebiotic galactooligosaccharide mixture (B-GOS) ameliorated abdominal pain, improved quality of life, and decreased incidence and duration of traveler’s diarrhea compared to placebo (4)
  • Undergraduate students in a state of stress were given various doses of galactooligosaccharides for 8 weeks and found that treatment decreased score of GI symptoms for diarrhea; 2.5 g of galactooligosaccharides decreased stress of any level while 5.0 g was found to be effective for only lower levels of stress (9)
  • Patients with C. difficile treated with prebiotic oligofructose for 30 days decreased incidence of relapse of diarrhea as shown by only 8.3% in treatment group having diarrhea relapse compared to 34.4% in placebo; additionally stool culture for treatment group demonstrated an increase in fecal bifidobacteria from 8.68 cfu/g to 9.37 cfu/g (11)
Prebiotics in the Fullscript catalog

Colostrum

200-400 mg, three times per day, as needed (16)(2)

  • Colostrum was effective for acute viral and bacterial diarrhea in children as demonstrated by a lower frequency of vomiting, diarrhea and vesikari score compared to placebo 48 hours after administration (2
  • Meta-analysis of childhood infectious diarrhea found colostrum to decrease occurrence of diarrhea by 71%, and reduce stool frequency by 1.42 times per day (12)
  • Adult patients given colostrum experienced decreased incidence of diarrhea, zonulin plasma levels, and plasma endotoxic concentration compared to placebo (5)
  • Healthy adult participants given 1200 mg daily bovine colostrum experienced 90.9% protection, compared to placebo, when challenged with an enterotoxic E. coli strain (16)
Colostrum in the Fullscript catalog

Zinc

15 mg per day, for a minimum of five days, in children (22)

  • Meta-analysis of acute diarrhea trials in children found zinc supplementation to decrease the duration of symptoms (24)
  • When provided with 15 mg/day for five days, the percentage of children with diarrhea decreased at hours 72 and 96 when treated with zinc as well as decreased duration of diarrhea compared to control group (22)
  • A systematic review and meta-analysis of children under age 5 with acute diarrhea showed decreased duration of diarrhea as well as incidence when given zinc compared to placebo and/or oral rehydration therapy; although risk of nausea and vomiting was higher in the zinc group (6)
  • Zinc supplementation decreased frequency of stools and duration of acute and persistent diarrhea in meta-analysis of children in developing countries with acute or persistent diarrhea; when comparing zinc formulations, zinc gluconate had more incidences of vomiting compared to zinc sulfate and zinc acetate (13)
  • Low dose (20 mg/day, 10-14 days) was found to be effective in treating diarrhea in children; Additionally vomiting decreased (3)
Zinc in the Fullscript catalog

Pectin

24 g, total per day, minimum 6 weeks (21)

  • Meta-analysis found that fiber (but not prebiotics) reduces the occurrence of diarrhea in patients receiving enteral nutrition (23)
  • Pectin reduced stool frequency, duration of symptoms, frequency of vomiting, need for oral rehydration and need for intravenous fluid in children aged 5-12 months with persistent diarrhea (18
  • IBS-D patients supplemented with pectin improved symptoms as shown by quality of life, composite symptom score; as well as improved immune function as shown by normalized IL-10/IL-12 ratio and improved faecal bacteria composition (increased bifidobacteria and decreased clostridium spp.) compared to placebo (21)
Pectin 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.

View template in-app
References
  1. Bae, J.-M. (2018). Prophylactic efficacy of probiotics on travelers’ diarrhea: an adaptive meta-analysis of randomized controlled trials. Epidemiology and Health, 40, e2018043. https://pubmed.ncbi.nlm.nih.gov/30189723/ (A)
  2. Barakat, S. H., Meheissen, M. A., Omar, O. M., & Elbana, D. A. (2020). Bovine Colostrum in the Treatment of Acute Diarrhea in Children: A Double-Blinded Randomized Controlled Trial. Journal of Tropical Pediatrics, 66(1), 46–55. https://pubmed.ncbi.nlm.nih.gov/31168590/ (B)
  3. Dhingra, U., Kisenge, R., Sudfeld, C. R., Dhingra, P., Somji, S., Dutta, A., Bakari, M., Deb, S., Devi, P., Liu, E., Chauhan, A., Kumar, J., Semwal, O. P., Aboud, S., Bahl, R., Ashorn, P., Simon, J., Duggan, C. P., Sazawal, S., & Manji, K. (2020). Lower-Dose Zinc for Childhood Diarrhea – A Randomized, Multicenter Trial. The New England Journal of Medicine, 383(13), 1231–1241. https://pubmed.ncbi.nlm.nih.gov/32966722/ (C)
  4. Drakoularakou, A., Tzortzis, G., Rastall, R. A., & Gibson, G. R. (2010). A double-blind, placebo-controlled, randomized human study assessing the capacity of a novel galacto-oligosaccharide mixture in reducing travellers’ diarrhoea. European Journal of Clinical Nutrition, 64(2), 146–152. https://pubmed.ncbi.nlm.nih.gov/19756029/ (B)
  5. Eslamian, G., Ardehali, S. H., Baghestani, A.-R., & Vahdat Shariatpanahi, Z. (2019). Effects of early enteral bovine colostrum supplementation on intestinal permeability in critically ill patients: A randomized, double-blind, placebo-controlled study. Nutrition , 60, 106–111. https://pubmed.ncbi.nlm.nih.gov/30551120/ (B)
  6. Galvao, T. F., Thees, M. F. R. e. S., Pontes, R. F., Silva, M. T., & Pereira, M. G. (2013). Zinc supplementation for treating diarrhea in children: a systematic review and meta-analysis. Revista Panamericana de Salud Publica = Pan American Journal of Public Health, 33(5), 370–377. https://pubmed.ncbi.nlm.nih.gov/23764669/ (A)
  7. GBD 2016 Diarrhoeal Disease Collaborators. (2018). Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet Infectious Diseases, 18(11), 1211–1228. https://pubmed.ncbi.nlm.nih.gov/30243583/ (F)
  8. Hempel, S., Newberry, S. J., Maher, A. R., Wang, Z., Miles, J. N. V., Shanman, R., Johnsen, B., & Shekelle, P. G. (2012a). Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis. JAMA: The Journal of the American Medical Association, 307(18), 1959–1969. https://pubmed.ncbi.nlm.nih.gov/22570464/ (A)
  9. Hughes, C., Davoodi-Semiromi, Y., Colee, J. C., Culpepper, T., Dahl, W. J., Mai, V., Christman, M. C., & Langkamp-Henken, B. (2011). Galactooligosaccharide supplementation reduces stress-induced gastrointestinal dysfunction and days of cold or flu: a randomized, double-blind, controlled trial in healthy university students. The American Journal of Clinical Nutrition, 93(6), 1305–1311. https://pubmed.ncbi.nlm.nih.gov/21525194/ (B)
  10. Ishaque, S. M., Khosruzzaman, S. M., Ahmed, D. S., & Sah, M. P. (2018a). A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterology, 18(1), 71. https://pubmed.ncbi.nlm.nih.gov/29801486/ (B)
  11. Lewis, S., Burmeister, S., & Brazier, J. (2005). Effect of the prebiotic oligofructose on relapse of Clostridium difficile-associated diarrhea: a randomized, controlled study. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 3(5), 442–448. https://pubmed.ncbi.nlm.nih.gov/15880313/ (B)
  12. Li, J., Xu, Y.-W., Jiang, J.-J., & Song, Q.-K. (2019). Bovine colostrum and product intervention associated with relief of childhood infectious diarrhea. Scientific Reports, 9(1), 3093. https://pubmed.ncbi.nlm.nih.gov/30816291/ (A)
  13. Lukacik, M., Thomas, R. L., & Aranda, J. V. (2008). A meta-analysis of the effects of oral zinc in the treatment of acute and persistent diarrhea. Pediatrics, 121(2), 326–336. https://pubmed.ncbi.nlm.nih.gov/18245424/ (A)
  14. Majeed, M., Nagabhushanam, K., Natarajan, S., Sivakumar, A., Ali, F., Pande, A., Majeed, S., & Karri, S. K. (2016a). Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study. Nutrition Journal, 15, 21. https://pubmed.ncbi.nlm.nih.gov/26922379/ (C) 
  15. McFarland, L. V. (2010). Systematic review and meta-analysis of Saccharomyces boulardii in adult patients. World Journal of Gastroenterology: WJG, 16(18), 2202–2222. https://pubmed.ncbi.nlm.nih.gov/20458757/ (A)
  16. Otto, W., Najnigier, B., Stelmasiak, T., & Robins-Browne, R. M. (2011). Randomized control trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by enterotoxigenic Escherichia coli in volunteers. Scandinavian Journal of Gastroenterology, 46(7-8), 862–868. https://pubmed.ncbi.nlm.nih.gov/21526980/ (C)
  17. Preston, K., Krumian, R., Hattner, J., de Montigny, D., Stewart, M., & Gaddam, S. (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://pubmed.ncbi.nlm.nih.gov/29888656/ (B)
  18. Rabbani, G. H., Teka, T., Zaman, B., Majid, N., Khatun, M., & Fuchs, G. J. (2001). Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology, 121(3), 554–560. https://pubmed.ncbi.nlm.nih.gov/11522739/ (C)
  19. Schiller, L. R., Pardi, D. S., & Sellin, J. H. (2017). Chronic Diarrhea: Diagnosis and Management. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 15(2), 182–193.e3. https://pubmed.ncbi.nlm.nih.gov/27496381/ (F)
  20. Steffen, R., Hill, D. R., & DuPont, H. L. (2015). Traveler’s diarrhea: a clinical review. JAMA: The Journal of the American Medical Association, 313(1), 71–80. https://pubmed.ncbi.nlm.nih.gov/25562268/ (F)
  21. Xu L., Yu W., Jiang J., Feng X., & Li N. (2015). [Efficacy of pectin in the treatment of diarrhea predominant irritable bowel syndrome]. Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery, 18(3), 267–271. https://pubmed.ncbi.nlm.nih.gov/25809332/ (C)
  22. Yazar, A. S., Güven, Ş., & Dinleyici, E. Ç. (2016). Effects of zinc or synbiotic on the duration of diarrhea in children with acute infectious diarrhea. The Turkish Journal of Gastroenterology: The Official Journal of Turkish Society of Gastroenterology, 27(6), 537–540. https://pubmed.ncbi.nlm.nih.gov/27852545/ (C)
  23. Kamarul Zaman, M., Chin, K.-F., Rai, V., & Majid, H. A. (2015). Fiber and prebiotic supplementation in enteral nutrition: A systematic review and meta-analysis. World Journal of Gastroenterology: WJG, 21(17), 5372–5381. https://pubmed.ncbi.nlm.nih.gov/25954112/ (A)
  24. Zou, T.-T., Mou, J., & Zhan, X. (2015). Zinc supplementation in acute diarrhea. Indian Journal of Pediatrics, 82(5), 415–420. https://pubmed.ncbi.nlm.nih.gov/24954892/ (A)