Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Randomized Controlled Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation - Trial of Bifidobacterium longum BB536 in Patients with Chronic Constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033031

Enrollment

Registered

2018-06-18

Start date

2018-06-18

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic Constipation

Interventions

Investigational Treatment: Bifidobacterium longum BB536 o.d. p.o. 4 weeks Comparative treatment: Placebo o.d. p.o. 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Age 65 or older 2)Patients with chronic constipation who satisfy the clinical criteria : a)Functional constipation or Constipation-predominant irritable bowel syndrome diagnosed by Rome4 b)constipation scoring system: 6 or more 3)Written informed consent provided for study participation

Exclusion criteria

Exclusion criteria: 1)Parkinson's disease, multiple sclerosis, cerebral infection, spinal cord lesion 2)uncontrolled Diabetes mellitus, Hypothyroidism, Uremia 3)Users of Opioid, Anticholinergics, Anticonvulsants, Antiemetics 4)Amyloidosis, systemic sclerosis, heavy metal poisoning 5)Severe disease(cerebro-vascular, he art, liver, renal , gastro-intestinal, end ocrine-metabolic, infectious disease). Cancer of the alimentary system. After gastrointestinal tract resection. Inflam matory bowel disease(IBD). 6)Users of antibiotic, medicine for intestinal disorders, irritative laxative, antidiarrheic and health food, supplement (lactic acid bacterium, bifidus bacillus, oligosaccharide,dietary fiber) 7) Remarkable abnormality for blood p ressure, blood test. Severe anemia. All ergy for drug and food. Heavy smoker, drinker. Irregular lifestyle such as a m eal, the sleep. 8) Considered by the principal investig ator to be ineligible.

Design outcomes

Primary

Measure	Time frame
constipation scoring system(CSS)	—

Secondary

Measure	Time frame
Bristol Stool Scale (BSS) FSSG(frequency scale for the symptoms of GERD) Izumo scale intestinal bacterial flora	—

Countries

Japan

Contacts

Public ContactTsutomu Takeda

Juntendo Tokyo Koto Geriatric Medical Center Department of Gastroenterology

t-takeda@juntendo.ac.jp+81-3-5632-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026