Effect of multi strain probiotics capsule on clinical symptoms and intestinal permeability in functional abdominal bloating and distension.

A Double-Blinded, Randomized, Placebo-controlled trial of multi strain probiotics capsule (Bifidobacterium long BB536, Lactobacillus acidophilus NCFM and Lactobacillus gasseri LAC343) on clinical symptoms and intestinal permeability in functional abdominal bloating and distension.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220323007

Enrollment

Registered

2022-03-23

Start date

2022-04-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional abdominal bloating and distension according to the ROME IV criteria. Bloating, Distension, Probiotics

Interventions

Multistrain probiotics capsule (Bifidobacterium longum BB536, Lactobacilus acidohilus NCFM and Lactobacillus gasser LAC343) (Biofit) 2 capsules once daily for 4 weeks ,Capsule containing non-active in

Experimental Dietary Supplement,Placebo Comparator Other

Multistrain probiotics capsule (Bifidobacterium longum BB536, Lactobacilus acidohilus NCFM and Lactobacillus gasser LAC343),Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.) 18-75 year old patients with a diagnosis of functional abdominal bloating and distension according to ROME IV criteria 2.) Functional abdominal bloating and distension symptoms are not improved after food-induced bloating and distension avoidance and restriction for 2 weeks

Exclusion criteria

Exclusion criteria: 1.) Previous abdominal surgery except appendectomy or cholecystectomy without complication 2.) Abnormal abdominal/pelvic structural such as abdominal infection, inflammatory bowel disease, gut obstruction, abdominal cancer, Celiac disease, lactose intolerance, fructose intolerance or pelvic floor dysfunction. 3.) Patients with diabetes, kidney disease, hypothyroidism, neurodegenerative disease, connective tissue disease, psychiatric problem, uncontrolled underlying disease 4.) Patients with NSAIDs, corticosteroids, antispasmodic, anti-flatulence, pro kinetic, tricyclic antidepressant, antibiotics, probiotics or opioid before inclusion in the study for 2 weeks 5.) Usual smoking or alcohol drinking 6.) Pregnant or breast feeding women 7.) Patients receive chemotherapy 8.) Patients with absolute neutrophil count less than 1000 mm3 9.) HIV infection with CD4 count less than 200 cell/mm3 10.) Allergy to one of the product ingredients or placebo

Design outcomes

Primary

Measure	Time frame
Clinical symptom 4 weeks Visual analog scale and Modified GIS rating scale ,Quality of life 4 weeks GIQoL	—

Secondary

Measure	Time frame
Intestinal permeability 4 weeks 2 sugar test probe (Lactulose/mannitol ratio),adverse effect at the end of study questionnaire	—

Countries

Thailand

Contacts

Public ContactPritsana Chuenprapai

Mahidol University

pritsana.chu@mahidol.act.th6616979551

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026