Probiotics Ameliorate Stool Consistency in Patients with Chronic Constipation: A Randomized, Double-Blind, Placebo-Controlled Study

Overview

Journal Dig Dis Sci

Specialty Gastroenterology

Date 2018 Jun 8

PMID 29876777

Citations 23

Authors

Jin Young Yoon

Jae Myung Cha

Ju Kyoung Oh

Pei Lei Tan

Sae Hun Kim

Min Seob Kwak

Jung Won Jeon

Hyun Phil Shin

Affiliations

Soon will be listed here.

Abstract

Background/aims: The efficacy of probiotics for improving clinical symptoms, altering the fecal microbiota, and regulating serum immune cytokine levels was investigated in patients with irritable bowel syndrome-constipation (IBS-C) or functional constipation (FC).

Methods: A randomized, double-blind, placebo-controlled trial was conducted at Kyung Hee University Hospital between October 2016 and February 2017. Consecutive 18-75-year-old patients with diagnosis of IBS-C or FC (based on Rome IV criteria) consumed probiotics (3.0 × 10 CFU/g Streptococcus thermophilus MG510 and 1.0 × 10 CFU/g Lactobacillus plantarum LRCC5193) or a placebo daily for 4 weeks (weeks 1-4) and were followed up for a 4-week washout period without intervention (weeks 5-8). The primary outcomes of the study were Bristol Stool Form Scale and Complete Spontaneous Bowel Movements (CSBM). Efficacy was assessed by per protocol.

Results: Stool consistency measured by the Bristol Stool Form Scale was significantly better in the probiotic group (n = 88) than in the placebo group (n = 83) at 4 and 8 weeks (3.7 ± 1.1 vs. 3.1 ± 1.1 at 8 weeks, P = 0.002). No significant difference was found in CSBM. The quality of life was significantly better in the probiotic group than in the placebo group at 4 weeks (P = 0.044) and 8 weeks (P = 0.049). The relative abundance of L. plantarum among the fecal microbiomes was significantly greater in the probiotic group than in the placebo group at 4 weeks (P = 0.029). However, the levels of other microbiomes and of serum cytokines (IL-10/IL-12 ratio and TNF-α) did not differ significantly between the two groups.

Conclusions: Probiotics significantly ameliorated stool consistency in patients with chronic constipation. In addition, the beneficial effect of L. plantarum on stool consistency remained after the probiotic supplementation was discontinued. The mechanism whereby probiotics benefit patients with chronic constipation should be clarified in further studies.

Citing Articles

Placebo response variability on health-related quality of life outcomes in irritable bowel syndrome: an arm-based network meta-analysis.

Wang Z, Chen Y, Li X, Lin L, Chen B, Chen M Qual Life Res. 2025; .

PMID: 39998756 DOI: 10.1007/s11136-025-03927-w.

Effect of Lacticaseibacillus rhamnosus IDCC 3201 on irritable bowel syndrome with constipation: a randomized, double-blind, and placebo-controlled trial.

Kwon H, Nam E, Kim H, Jo H, Bang W, Lee M Sci Rep. 2024; 14(1):22384.

PMID: 39333245 PMC: 11437119. DOI: 10.1038/s41598-024-72887-x.

Efficacy and Safety of LBSC in Drug Induced Constipation Associated With Functional Gastrointestinal Disorder: A Double-Blind, Randomized, Interventional, Parallel, Controlled Trial a Clinical Study on LBSC for Drug Induced Constipation Associated....

Rathi A, Pagare R Glob Adv Integr Med Health. 2024; 13:27536130241286511.

PMID: 39295947 PMC: 11409293. DOI: 10.1177/27536130241286511.

Evaluating the Effect of Strain Shirota on the Physical Consistency of Stool in Healthy Participants with Hard or Lumpy Stools: A Double-Blind, Randomized, Placebo-Controlled Study.

Tsujibe S, Gawad A, Shigehisa A, Matsuda K, Fujimoto J, Takahashi T Nutrients. 2024; 16(15).

PMID: 39125350 PMC: 11313875. DOI: 10.3390/nu16152469.

Microbiota treatment of functional constipation: Current status and future prospects.

Li Y, Zhang X, Wang Z World J Hepatol. 2024; 16(5):776-783.

PMID: 38818289 PMC: 11135260. DOI: 10.4254/wjh.v16.i5.776.

References

Lee E, Kwon O, Hahm K, Kim W, Kim J, Cheung D . Irritable bowel syndrome-specific health-related quality of life instrument: development and psychometric evaluation. Health Qual Life Outcomes. 2016; 14:22. PMC: 4756460. DOI: 10.1186/s12955-016-0423-9. View

Sondergaard B, Olsson J, Ohlson K, Svensson U, Bytzer P, Ekesbo R . Effects of probiotic fermented milk on symptoms and intestinal flora in patients with irritable bowel syndrome: a randomized, placebo-controlled trial. Scand J Gastroenterol. 2011; 46(6):663-72. DOI: 10.3109/00365521.2011.565066. View

Enck P, Zimmermann K, Menke G, Klosterhalfen S . Randomized controlled treatment trial of irritable bowel syndrome with a probiotic E.-coli preparation (DSM17252) compared to placebo. Z Gastroenterol. 2009; 47(2):209-14. DOI: 10.1055/s-2008-1027702. View

Cui S, Hu Y . Multistrain probiotic preparation significantly reduces symptoms of irritable bowel syndrome in a double-blind placebo-controlled study. Int J Clin Exp Med. 2012; 5(3):238-44. PMC: 3403550. View

Simren M, Barbara G, Flint H, Spiegel B, Spiller R, Vanner S . Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2012; 62(1):159-76. PMC: 3551212. DOI: 10.1136/gutjnl-2012-302167. View

Williams E, Stimpson J, Wang D, Plummer S, Garaiova I, Barker M . Clinical trial: a multistrain probiotic preparation significantly reduces symptoms of irritable bowel syndrome in a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2008; 29(1):97-103. DOI: 10.1111/j.1365-2036.2008.03848.x. View

Choi C, Jo S, Park H, Chang S, Byeon J, Myung S . A randomized, double-blind, placebo-controlled multicenter trial of saccharomyces boulardii in irritable bowel syndrome: effect on quality of life. J Clin Gastroenterol. 2011; 45(8):679-83. DOI: 10.1097/MCG.0b013e318204593e. View

Videlock E, Cheng V, Cremonini F . Effects of linaclotide in patients with irritable bowel syndrome with constipation or chronic constipation: a meta-analysis. Clin Gastroenterol Hepatol. 2013; 11(9):1084-1092.e3. DOI: 10.1016/j.cgh.2013.04.032. View

Yoon H, Park Y, Lee D, Seo J, Shin C, Kim N . Effect of administering a multi-species probiotic mixture on the changes in fecal microbiota and symptoms of irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Biochem Nutr. 2015; 57(2):129-34. PMC: 4566021. DOI: 10.3164/jcbn.15-14. View

10.

Saad R, Rao S, Koch K, Kuo B, Parkman H, McCallum R . Do stool form and frequency correlate with whole-gut and colonic transit? Results from a multicenter study in constipated individuals and healthy controls. Am J Gastroenterol. 2009; 105(2):403-11. DOI: 10.1038/ajg.2009.612. View

11.

Begtrup L, de Muckadell O, Kjeldsen J, Christensen R, Jarbol D . Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial. Scand J Gastroenterol. 2013; 48(10):1127-35. DOI: 10.3109/00365521.2013.825314. View

12.

Solem C, Patel H, Mehta S, Mody R, Macahilig C, Gao X . Treatment patterns, symptom reduction, quality of life, and resource use associated with lubiprostone in irritable bowel syndrome constipation subtype. Curr Med Res Opin. 2016; 32(5):899-905. DOI: 10.1185/03007995.2016.1150262. View

13.

Ford A, Quigley E, Lacy B, Lembo A, Saito Y, Schiller L . Efficacy of prebiotics, probiotics, and synbiotics in irritable bowel syndrome and chronic idiopathic constipation: systematic review and meta-analysis. Am J Gastroenterol. 2014; 109(10):1547-61. DOI: 10.1038/ajg.2014.202. View

14.

Ramos-Romero S, Hereu M, Molinar-Toribio E, Almajano M, Mendez L, Medina I . Effects of the combination of ω-3 PUFAs and proanthocyanidins on the gut microbiota of healthy rats. Food Res Int. 2017; 97:364-371. DOI: 10.1016/j.foodres.2017.04.024. View

15.

Hong K, Kang H, Im J, Ji G, Kim S, Jung H . Effect of probiotics on symptoms in korean adults with irritable bowel syndrome. Gut Liver. 2010; 3(2):101-7. PMC: 2852694. DOI: 10.5009/gnl.2009.3.2.101. View

16.

Bashashati M, Rezaei N, Shafieyoun A, McKernan D, Chang L, Ohman L . Cytokine imbalance in irritable bowel syndrome: a systematic review and meta-analysis. Neurogastroenterol Motil. 2014; 26(7):1036-48. DOI: 10.1111/nmo.12358. View

17.

Johanson J, Kralstein J . Chronic constipation: a survey of the patient perspective. Aliment Pharmacol Ther. 2007; 25(5):599-608. DOI: 10.1111/j.1365-2036.2006.03238.x. View

18.

Singh G, Lingala V, Wang H, Vadhavkar S, Kahler K, Mithal A . Use of health care resources and cost of care for adults with constipation. Clin Gastroenterol Hepatol. 2007; 5(9):1053-8. DOI: 10.1016/j.cgh.2007.04.019. View

19.

Guglielmetti S, Mora D, Gschwender M, Popp K . Randomised clinical trial: Bifidobacterium bifidum MIMBb75 significantly alleviates irritable bowel syndrome and improves quality of life--a double-blind, placebo-controlled study. Aliment Pharmacol Ther. 2011; 33(10):1123-32. DOI: 10.1111/j.1365-2036.2011.04633.x. View

20.

OMahony L, McCarthy J, Kelly P, Hurley G, Luo F, Chen K . Lactobacillus and bifidobacterium in irritable bowel syndrome: symptom responses and relationship to cytokine profiles. Gastroenterology. 2005; 128(3):541-51. DOI: 10.1053/j.gastro.2004.11.050. View