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

Chronic difficulties with infrequent bowel movements are one of the most common gastrointestinal disorders. (4) According to a systematic review published in 2011, median global prevalence in the general population is roughly 16%. (16) 

Notably, a recent survey found that of Americans with constipation, only 37.6% had a discussion about their symptoms. (19) Gastrointestinal health greatly impacts quality of life, and chronic constipation decreases both mental and physical aspects of it. (3) 

The protocol presented below suggests ingredients with demonstrated effectiveness for a variety of factors associated with infrequent and/or hard stools. 

Inulin

12-15 g per day, for a minimum of 4 weeks (11)(14)

  • A meta-analysis found inulin to be effective in improving stool frequency and consistency according to the bristol scale (6) 
  • Inulin supplementation increased stool frequency to a median of 4 per week (3 per week in placebo) in healthy adults with constipation; stool consistency softened and overall satisfaction increased (14)
  • Elderly volunteers supplemented with inulin experienced decreased difficulty with defecation; stool analysis demonstrated an increase in bifidobacteria as well as total fecal bacterial count (11)
  • Children given 2 g twice per day of Orafti® inulin-type fructans for 6 weeks experienced softened stool consistency as shown by an increase from 2.2 to 2.6 on modified bristol scale for children (5)
Inulin in the Fullscript catalog

Probiotics

1-10 billion CFU, total per day, minimum 28 days (8)(7) 

  • Adults with functional constipation having fewer than 3 bowel movements per week experienced an increased number of bowel movements per week when supplemented with 1 billion or 10 billion cfu per day of Bifidobacterium animalis subsp. lactis HN019 compared to placebo, as well as decreasing the degree of strain to pass stool (8) 
  • Probiotics improved constipation by 10-40% compared to placebo in a systematic review of constipation in elderly people; notably the most commonly tested strain of probiotic was bifidobacterium longum (12)
  • Irritable bowel syndrome-primary constipation (IBS-C) and functional constipation patients improved stool consistency as demonstrated by bristol stool scale, and increased quality of life at weeks 4 and 8 when supplemented with 300 million CFU/g Streptococcus thermophilus MG510 and 100 million CFU/g Lactobacillus plantarum LRCC5193 compared to placebo (23)
  • Mixed probiotic formulation decreased flatulence and decreased the mean AUC of all symptoms in adults with constipation compared to placebo (1)
Probiotics in the Fullscript catalog

Psyllium husk

10-20 g, total per day, minimum 8 weeks (2)(18) 

  • Improvement in stool consistency and pain on defecation was observed when given 5 grams per day for 8 weeks when given 5 grams twice per day for 8 weeks (2)  
  • Meta-analysis found psyllium to be effective in increasing stool frequency (22) 
  • Supplementation for 12 weeks (10 g total per day) decreased constipation in patients with type 2 diabetes (18) 
  • Psyllium given in addition to docusate sodium improved stool composition compared to docusate sodium alone, as demonstrated by increased stool water content, increased total stool output, and increased frequency of bowel movements (3.5 BM/week in psyllium, 2.9 BM/week in docusate), in patients with chronic idiopathic constipation (13) 
  • Chronically constipated adults experienced improved MRI-measured descending colonic chyme, fasting colonic volume, and mean postprandial small bowel water when supplemented with 7 g of psyllium three times per day (9)
Psyllium husk in the Fullscript catalog

Senna

8.6 mg total per day, as needed (20)

  • When compared with lubiprostone, senna capsules were found to have similar efficacy in alleviating opioid induced constipation as demonstrated by an improvement in patient assessment of constipation (PAC)-symptoms (PAC-SYM) and the PAC-quality of life (PAC-QOL) score; the only difference found between groups was for completeness of bowel movement in which lubiprostone was favored, and reduction of abdominal pain in which senna being favored (10)
  • Senna was more effective for fecal continence and constipation when compared with polyethylene glycol in children with corrected anorectal malformations (24)
  • When given in addition to docusate, 8.6 mg of senna improved time to first bowel movement; additionally, only 7.0% of patients requested magnesium citrate to initiate a bowel movement compared to 43.6% in placebo with docusate (20)
Senna in the Fullscript catalog

Magnesium

400-800 mg magnesium oxide for 1-2 weeks (variable based on form and body weight) (15)(21)

  • When given 800 mg of magnesium oxide, overall incidence of constipation decreased as well as atrial fibrillation, nausea and vomiting, in patients undergoing cardiac bypass surgery compared to control (15)
  • Intestinal transit improved as shown by increased duodenal-cecal transit time, fecal fat, fecal weight, postprandial gallbladder relaxation, peptide YY release, and delayed fasting recurrence of phase II and affected antroduodenal motility when given oral magnesium sulphate with a meal compared to placebo (21)
  • 57.5% of children given magnesium oxide (125 mg of magnesium oxide three times per day for children less than 20 kg or 250 mg three times per day for those weighing more than 20 kg) achieved good response of 3 or more bowel movements per week compared to 68.2% of children taking cisapride (0.2mg/kg) after 1 week of therapy (17)
Magnesium 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.

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References
  1. Airaksinen, K., Yeung, N., Lyra, A., Lahtinen, S. J., Huttunen, T., Shanahan, F., & Ouwehand, A. C. (2019). The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: a double blind, randomised, placebo controlled 2-week trial. Beneficial Microbes, 10(6), 617–627. https://pubmed.ncbi.nlm.nih.gov/31131616/ (B)
  2. Ashraf, W., Park, F., Lof, J., & Quigley, E. M. (1995). Effects of psyllium therapy on stool characteristics, colon transit and anorectal function in chronic idiopathic constipation. Alimentary Pharmacology & Therapeutics, 9(6), 639–647. https://pubmed.ncbi.nlm.nih.gov/8824651/ (C)
  3. Belsey, J., Greenfield, S., Candy, D., & Geraint, M. (2010). Systematic review: impact of constipation on quality of life in adults and children. Alimentary Pharmacology & Therapeutics, 31(9), 938–949. https://pubmed.ncbi.nlm.nih.gov/20180788/ (A)
  4. Black, C. J., & Ford, A. C. (2018). Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management. The Medical Journal of Australia, 209(2), 86–91. https://pubmed.ncbi.nlm.nih.gov/29996755/ (F)
  5. Closa-Monasterolo, R., Ferré, N., Castillejo-DeVillasante, G., Luque, V., Gispert-Llaurado, M., Zaragoza-Jordana, M., Theis, S., & Escribano, J. (2017). The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. International Journal of Food Sciences and Nutrition, 68(5), 587–594. https://pubmed.ncbi.nlm.nih.gov/27931142/ (C)
  6. Collado Yurrita, L., San Mauro Martín, I., Ciudad-Cabañas, M. J., Calle-Purón, M. E., & Hernández Cabria, M. (2014). Effectiveness of inulin intake on indicators of chronic constipation; a meta-analysis of controlled randomized clinical trials. Nutricion Hospitalaria: Organo Oficial de La Sociedad Espanola de Nutricion Parenteral Y Enteral, 30(2), 244–252. https://pubmed.ncbi.nlm.nih.gov/25208775/ (A)
  7. Drouault-Holowacz, S., Bieuvelet, S., Burckel, A., Cazaubiel, M., Dray, X., & Marteau, P. (2008). A double blind randomized controlled trial of a probiotic combination in 100 patients with irritable bowel syndrome. Gastroenterologie Clinique et Biologique, 32(2), 147–152. https://pubmed.ncbi.nlm.nih.gov/18387426/ (B)
  8. Ibarra, A., Latreille-Barbier, M., Donazzolo, Y., Pelletier, X., & Ouwehand, A. C. (2018). Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: A double-blind, randomized, placebo-controlled, and dose-ranging trial. Gut Microbes, 9(3), 236–251. https://pubmed.ncbi.nlm.nih.gov/29227175/ (B)
  9. Major, G., Murray, K., Singh, G., Nowak, A., Hoad, C. L., Marciani, L., Silos-Santiago, A., Kurtz, C. B., Johnston, J. M., Gowland, P., & Spiller, R. (2018). Demonstration of differences in colonic volumes, transit, chyme consistency, and response to psyllium between healthy and constipated subjects using magnetic resonance imaging. Neurogastroenterology and Motility: The Official Journal of the European Gastrointestinal Motility Society, 30(9), e13400. https://pubmed.ncbi.nlm.nih.gov/30062794/ (C)
  10. Marciniak, C. M., Toledo, S., Lee, J., Jesselson, M., Bateman, J., Grover, B., & Tierny, J. (2014). Lubiprostone vs Senna in postoperative orthopedic surgery patients with opioid-induced constipation: a double-blind, active-comparator trial. World Journal of Gastroenterology: WJG, 20(43), 16323–16333. https://pubmed.ncbi.nlm.nih.gov/25473191/ (C)
  11. Marteau, P., Jacobs, H., Cazaubiel, M., Signoret, C., Prevel, J.-M., & Housez, B. (2011). Effects of chicory inulin in constipated elderly people: a double-blind controlled trial. International Journal of Food Sciences and Nutrition, 62(2), 164–170. https://pubmed.ncbi.nlm.nih.gov/21091293/ (C)
  12. Martínez-Martínez, M. I., Calabuig-Tolsá, R., & Cauli, O. (2017). The effect of probiotics as a treatment for constipation in elderly people: A systematic review. Archives of Gerontology and Geriatrics, 71, 142–149. https://pubmed.ncbi.nlm.nih.gov/28467916/ (A)
  13. McRorie, J. W., Daggy, B. P., Morel, J. G., Diersing, P. S., Miner, P. B., & Robinson, M. (1998). Psyllium is superior to docusate sodium for treatment of chronic constipation. Alimentary Pharmacology & Therapeutics, 12(5), 491–497. https://pubmed.ncbi.nlm.nih.gov/9663731/ (B)
  14. Micka, A., Siepelmeyer, A., Holz, A., Theis, S., & Schön, C. (2017). Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. International Journal of Food Sciences and Nutrition, 68(1), 82–89. https://pubmed.ncbi.nlm.nih.gov/27492975/ (C)
  15. Moradian, S. T., Ghiasi, M. S., Mohamadpour, A., & Siavash, Y. (2017). Oral magnesium supplementation reduces the incidence of gastrointestinal complications following cardiac surgery: a randomized clinical trial. Magnesium Research: Official Organ of the International Society for the Development of Research on Magnesium, 30(1), 28–34. https://pubmed.ncbi.nlm.nih.gov/28417897/ (C)
  16. Mugie, S. M., Benninga, M. A., & Di Lorenzo, C. (2011). Epidemiology of constipation in children and adults: a systematic review. Best Practice & Research. Clinical Gastroenterology, 25(1), 3–18. https://pubmed.ncbi.nlm.nih.gov/21382575/ (A)
  17. Ni, Y. H., Lin, C. C., Chang, S. H., Yeung, C. Y., & Taiwan Pediatric Constipation Study Group. (2001). Use of cisapride with magnesium oxide in chronic pediatric constipation. Acta Paediatrica Taiwanica = Taiwan Er Ke Yi Xue Hui Za Zhi, 42(6), 345–349. https://pubmed.ncbi.nlm.nih.gov/11811223/ (C)
  18. Noureddin, S., Mohsen, J., & Payman, A. (2018). Effects of psyllium vs. placebo on constipation, weight, glycemia, and lipids: A randomized trial in patients with type 2 diabetes and chronic constipation. Complementary Therapies in Medicine, 40, 1–7. https://pubmed.ncbi.nlm.nih.gov/30219432/ (B)
  19. Oh, S. J., Fuller, G., Patel, D., Khalil, C., Spalding, W., Nag, A., Spiegel, B. M. R., & Almario, C. V. (2020). Chronic Constipation in the United States: Results From a Population-Based Survey Assessing Healthcare Seeking and Use of Pharmacotherapy. The American Journal of Gastroenterology, 115(6), 895–905. https://pubmed.ncbi.nlm.nih.gov/32324606/ (D)
  20. Patel, M., Schimpf, M. O., O’Sullivan, D. M., & LaSala, C. A. (2010). The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. American Journal of Obstetrics and Gynecology, 202(5), 479.e1–e5. https://pubmed.ncbi.nlm.nih.gov/20207340/ (B)
  21. Vu, M. K., Nouwens, M. A., Biemond, I., Lamers, C. B., & Masclee, A. A. (2000). The osmotic laxative magnesium sulphate activates the ileal brake. Alimentary Pharmacology & Therapeutics, 14(5), 587–595. https://pubmed.ncbi.nlm.nih.gov/10792122/ (C)
  22. Yang, J., Wang, H.-P., Zhou, L., & Xu, C.-F. (2012). Effect of dietary fiber on constipation: a meta analysis. World Journal of Gastroenterology: WJG, 18(48), 7378–7383. https://pubmed.ncbi.nlm.nih.gov/23326148/ (A)
  23. Yoon, J. Y., Cha, J. M., Oh, J. K., Tan, P. L., Kim, S. H., Kwak, M. S., Jeon, J. W., & Shin, H. P. (2018). Probiotics Ameliorate Stool Consistency in Patients with Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Study. Digestive Diseases and Sciences, 63(10), 2754–2764. https://pubmed.ncbi.nlm.nih.gov/29876777/ (B)
  24. Zhong, L. L. D., Cheng, C.-W., Kun, W., Dai, L., Hu, D.-D., Ning, Z.-W., Xiao, H.-T., Lin, C.-Y., Zhao, L., Huang, T., Tian, K., Chan, K.-H., Lam, T.-W., Chen, X.-R., Wong, C.-T., Li, M., Lu, A.-P., Wu, J. C. Y., & Bian, Z.-X. (2019). Efficacy of MaZiRenWan, a Chinese Herbal Medicine, in Patients With Functional Constipation in a Randomized Controlled Trial. Clinical Gastroenterology and Hepatology: The Official Clinical Practice Journal of the American Gastroenterological Association, 17(7), 1303–1310.e18. https://pubmed.ncbi.nlm.nih.gov/29654915/ (B)