Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lactobacillus plantarum IS-10506 · 1 trial · 1 indication
Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction. * Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome * Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome * Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome * Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction • Total score, minimum score -20, maximum score 92, lower value represents better outcome
| Arm | Type | Description |
|---|---|---|
| Probiotic | EXPERIMENTAL | Lactobacillus plantarum IS-10506 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Lactobacillus plantarum IS-10506 | DRUG | Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks. |
| Placebo | DRUG | Fermented milk containing placebo to be consumed once daily for three weeks. |
Inclusion Criteria: * Being declared healthy based on initial examination and the Structured Interview Questionnaire (SIQ) * Having the symptoms and signs of functional constipation refer to ROME IV * Able to communicate well * Able to consume 1 bottle of fermented milk each day for three weeks * N...
Lactobacillus plantarum IS-10506 is an investigational probiotic being studied for the treatment of functional constipation, a gastrointestinal condition characterized by difficult or infrequent bowel movements. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Lactobacillus plantarum IS-10506 is being developed by United Therapeutics Corporation, a publicly traded biopharmaceutical company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical research to evaluate the probiotic's potential as a treatment for functional constipation.
Lactobacillus plantarum IS-10506 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for functional constipation.
Lactobacillus plantarum IS-10506 has one completed Phase 2 clinical trial registered under NCT03829358, titled 'The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation.' The study enrolled 76 female participants in Indonesia and was a randomized, double-blind, placebo-controlled trial.
Lactobacillus plantarum IS-10506 is a specific strain of the Lactobacillus plantarum species, which belongs to a group of bacteria commonly used as probiotics. While other products may contain different strains of Lactobacillus plantarum, IS-10506 is a distinct strain being investigated for its potential effects on functional constipation.