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Completed

NCT Number: NCT03829358

The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation

This study aimed to investigate the relationship between administration of probiotics and improvement in quality of life in women with functional constipation.

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Key information

Conditions

Constipation - Functional Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Puskesmas Petamburan

Jakarta, DKI Jakarta, 11440, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Not using antibiotic no later than one week before supplementation

Exclusion criteria

  • Diagnosed with functional bowel disorder
  • Using anesthesia at least 4 weeks before treatment
  • Having a serious pathological disorder (carcinoma)
  • During healing phase of acute gastrointestinal disorders at least 4 weeks before treatment
  • Having severe heart disease
  • Taking chronic medications such as antidepressants or analgesics

Treatment and study plan

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.

Primary outcomes

  1. Improvement in quality of life

    Time frame: Three weeks after intervention.

    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

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Official study title

The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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