A Randomized, Placebo-Controlled Trial Evaluating Multi-Species Synbiotic Supplementation for Bloating, Gas, and Abdominal Discomfort.

The multi-species synbiotic improved GI quality-of-life compared to placebo at Week 6.

• DQLQ scores were 0.80 (synbiotic) vs. 1.20 (placebo) at Week 6 (p < 0.05).
• The trial was a randomized, double-blind, placebo-controlled, decentralized design with n = 350 participants.
• Participants had self-reported bloating/indigestion and received treatment daily for 6 weeks.
• The synbiotic contained 53.6 billion AFU multi-species probiotic and 400 mg pomegranate extract (DS-01).

Bloating and gas were significantly reduced in the synbiotic arm compared to placebo.

• PROMIS-GI 13a scores were 16.0 (synbiotic) vs. 21.0 (placebo) (p < 0.01).
• More participants in the synbiotic arm reported never/rarely bloating: 72.3% vs. 55.9% (p < 0.001).
• This is described as the first synbiotic to demonstrate meaningful improvements in bloating and gas in a generally healthy, diverse, real-world population.

Abdominal discomfort was significantly decreased in the synbiotic arm compared to placebo.

• PROMIS-GI 5a scores were 8.0 (synbiotic) vs. 10.0 (placebo) (p < 0.01).
• Abdominal discomfort was measured using the PROMIS-GI 5a instrument.
• The reduction was observed after 6 weeks of daily supplementation.

The multi-species synbiotic produced statistically significant improvements in constipation symptoms and bowel regularity relative to placebo.

• Both constipation symptoms and regularity outcomes were statistically significantly improved in the synbiotic arm compared to placebo.
• Specific numerical values for constipation and regularity outcomes were not reported in the abstract.
• These improvements were observed over the 6-week intervention period.

Probiotics can alleviate some gastrointestinal symptoms, but evidence for their impact on bloating, gas, and abdominal discomfort in otherwise healthy populations remains limited prior to this trial.

• Mechanistic studies suggest synbiotics may influence underlying mechanisms of bloating, including increased gas production, impaired gut motility, and visceral hypersensitivity.
• The authors note 'a paucity of data from large trials evaluating clinical outcomes' for synbiotics in this context.
• The study population consisted of generally healthy individuals with self-reported bloating/indigestion, not patients with diagnosed GI disorders.

The trial enrolled 350 participants with self-reported bloating/indigestion in a decentralized, double-blind, placebo-controlled design.

• Participants were randomized to receive either DS-01 (53.6 billion AFU multi-species probiotic and 400 mg pomegranate extract) or placebo daily for 6 weeks.
• Outcomes measured included GI quality-of-life (DQLQ), bloating and gas (PROMIS-GI 13a), abdominal discomfort (PROMIS-GI 5a), constipation, regularity, mood-related symptoms, and safety.
• The decentralized trial design was used, described as evaluating a 'diverse, real-world population'.