The effect of a probiotic blend on gastrointestinal symptoms in constipated patients: a double blind, randomised, placebo controlled 2-week trial

Abstract

Selected strains of lactobacilli and bifidobacteria are known to ameliorate constipation-related symptoms and have previously shown efficacy on digestive health. In this clinical trial, the safety and effectiveness of a probiotic blend containing lactobacilli and bifidobacteria were evaluated in adults with self-reported bloating and functional constipation. Constipation was diagnosed by the Rome III criteria. A total of 156 adults were randomised into this double-blind and placebo-controlled trial. Participants consumed the combination of Lactobacillus acidophilus NCFM (1010 cfu), Lactobacillus paracasei Lpc-37 (2.5×109 cfu), Bifidobacterium animalis subsp. lactis strains Bl-04 (2.5×109 cfu), Bi-07 (2.5×109 cfu) and HN019 (1010 cfu) (n=78), or placebo (microcrystalline cellulose) (n=78) for two weeks. After treatment the following were measured: primary outcome of bloating and secondary outcomes of colonic transit time, bowel movement frequency, stool consistency, other gastrointestinal symptoms (flatulence, abdominal pain, and burbling), constipation-related questionnaires (PAC-SYM and PAC-QoL) and product satisfaction. Faecal recovery of consumed strains was determined. The enrolled population was defined as constipated, however, the initial bloating severity was lower than in previous similar studies. No clinically significant observations related to the safety of the product were reported. Product efficacy was not shown in the primary analysis for bloating nor for the secondary efficacy analyses. The placebo functioned similarly as the probiotic product. In post-hoc analysis, a statistically significant decrease in flatulence in favour of the probiotic group was observed; day 7 (intention-to-treat (ITT): P=0.0313; per-protocol (PP): 0.0253) and on day 14 (ITT: P=0.0116; PP: P=0.0102) as measured by area under the curve (AUC) analysis. The mean AUC of all symptoms decreased in favour of the probiotic group, indicating less digestive discomfort. The study was registered at the ISRCTN registry (ISRCTN41607808).

Bifidobacterium animalis subsp. lactis HN019 Effects on Gut Health: A Review

“…Therefore, endogenous and consumed bifidobacteria, including B. lactis HN019™, could divert the fermentation in the colon toward non-gaseous end-products. This property of B. lactis HN019™ may support tolerance for the fermentation of oligosaccharides in vivo , which is in line with clinical observations of B. lactis HN019™ on reduced flatulence ( 21 , 32 ). In addition, lactate and acetate are produced during B. lactis HN019™ fermentation, indicating potential roles in digestion of dietary components without differentiation of the origin; carbohydrate or protein ( 89 , 102 ).…”

“…In Ibarra et al ( 22 ), when comparing the measured gastrointestinal symptoms between subjects taken B. lactis HN019™ vs. placebo, only a reduction observed in the degree of straining in the sub-group of subjects (BMF<3). Improvements of gastrointestinal symptoms were also observed in studies with B. lactis HN019™ in combination with other probiotics or prebiotics ( 21 , 27 ) ( Table 1 ).…”

Fecal Recovery of Probiotics Administered as a Multi-Strain Formulation during Antibiotic Treatment

“…The low detection of L. acidophilus NCFM is difficult to explain, as earlier studies have reported substantially higher fecal recovery levels: 6.6 and 6.7 Log10 genomes/g feces [12,13]. The number of subjects with detectable probiotics was similar for L. paracasei Lpc-37, B. lactis Bl-04, and B. lactis Bi-07, but was less for L. acidophilus NCFM; this is in line with earlier observations on fecal recovery of these strains in healthy subjects not consuming antibiotics [9].…”

Role of gut microbiota in functional constipation

“…[ 78 ]. Although individual studies have reported varied efficacies [ 79 , 80 ], an earlier systemic review and meta-analysis of randomized–controlled trials indicated that probiotics may improve the whole-gut transit time, stool frequency, and stool consistency; Bifidobacterium lactis showed better efficacies than Lactobacillus casei Shirota [ 81 ]. A more recent systemic review and meta-analysis arrived at a similar conclusion that probiotics increase stool frequency and decrease intestinal transit time in FC patients [ 82 ].…”