B. longum 3562 Improves IBS Severity in Children but Does Not Persist after Intake

A study presented at the 2024 Annual North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) Meeting in Hollywood, Florida, from November 7 to 9, 2024 showed B. longum 3562 may improve irritable bowel syndrome (IBS) symptoms in children and adolescents, even those with vitamin D deficiency.¹

A total of 12% - 48% of children in Latin America have disorders of gut-brain interaction, such as IBS. Research has shown probiotic supplementation with Bifidobacterium longum 35624TM reduced IBS symptom severity in adults.² Investigators conducted a real-world, open-label, single-arm study to examine the effects of B. longum 35624 on IBS symptoms in 64 children and adolescents aged 8 – 18 years (mean age: 12.3 years; 65.6% female) from Chile.¹ Investigators also assessed the effect of B. longum 35624 on IBS symptoms in patients with vitamin D deficiency.

“The most important findings [are] that the children [on B. longum 35624] probiotics have [an] improvement in all the symptoms, especially pain, distension and the station stools, and they have a very better quality of life,” lead investigator Sylvia Cruchet Muñoz, from the Universidad de Chile Instituto de Nutricion y Tecnologia de los Alimentos, Macul, Región Metropolitana in Chile, told HCPLive at NASPGHAN.

Children and adolescents included had pain for ≥ 3 months. Among the sample, 67.2% and 29.7% had severe or moderate IBS with concurrent DGBI, such as functional abdominal pain not otherwise specified (93.8%), functional dyspepsia (70.3%), and functional constipation (67.2%).

The treatment period included receiving B. longum 35624 (1x109 colony-forming units/day) for 12 weeks, followed by a 2-week washout. At baseline and weeks 6, 12, and 14, Muñoz and colleagues measured abdominal pain frequency, abdominal pain severity, abdominal distension severity, bowel habit satisfaction, and impact to life using an IBS severity scoring system (IBS-SSS). The number of symptoms was measured at baseline, week 6, and week 12 with the adapted Questionnaire on Pediatric Gastrointestinal Symptoms.

Mean IBS severity scores in the IBS-SSS significantly decreased from baseline (334.4 ± 76.67) to week 6 (104.3 ± 92.36, P < .0001) and week 12 (57.6 ± 71.6, P <.0001). Most participants (96.6%) had a clinically significant improvement, with a change of> 50 points, in the composite IBS-SSS score.

Moreover, participants had improvements from baseline in all IBS-SSS domain scores at week 6 (P < .0001) except for bowel habit satisfaction (P < .0007). Participants also demonstrated improvements from baseline in all IBS-SS domains at week 12 (P < .0001).

Furthermore, 98.3% of participants experienced numerical improvements in ≥ 3 domains. Investigators observed the IBS-SSS severity categories shifted from moderate/severe at baseline to mild/remission (P < .0001). However, despite these findings, the improvements in symptom severity did not remain during the 2-week washout.

“Effects were not maintained after cessation of probiotic intake, suggesting the need for continuous probiotic supplementation for long-term benefits,” investigators wrote.

The team also evaluated the impact of vitamin D status on the probiotic response and symptom severity in a post-hoc analysis. Low serum vitamin D levels at baseline (mean 19.7ng/mL) did not influence baseline IBS severity (P = .59) or probiotic response (P = .79).

The study showed the number of IBS symptoms significantly reduced from baseline (9.6 ± 4.9) to week 6 (6.9 ± 4.9, P = .0005) and week 12 (6.9 ± 5.4, P = .02).

“The open-label study design introduced a potential placebo effect,” investigators wrote. “However, the scale of improvement in IBS-SSS scores, the 50-point threshold for clinically meaningful results, and the consistency with findings from published placebo-controlled studies of this strain in adult IBS populations suggests a true probiotic effect. A larger randomized controlled trial is needed to confirm these findings and further analyze the relationship between probiotic response and vitamin D status.”

References

1. ^{Muñoz, S, Palma, S, Marqués, L, et al. EFFECTS OF BIFIDOBACTERIUM LONGUM 35624 IN CHILDREN AND ADOLESCENTS WITH IRRITABLE BOWEL SYNDROME – A REAL WORLD STUDY IN CHILE. Presented at NASPHGAN 2024 in Hollywood, Florida, from November 7 – November 9, 2024.}
2. ^{Sabaté JM, Iglicki F. Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome. World J Gastroenterol. 2022 Feb 21;28(7):732-744. doi: 10.3748/wjg.v28.i7.732. PMID: 35317278; PMCID: PMC8891724.}