TCI604 probiotic to improve intestinal function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–65 diagnosed with functional constipation will be assigned to receive either the TCI604 probiotic (containing Bifidobacterium animalis subsp. lactis) or a matching placebo. Participants with recent probiotic or antibiotic use, chronic gastrointestinal diseases, or major organ or psychiatric conditions are excluded. The intervention is administered at National Taiwan University Hospital with clinical follow-up and symptom monitoring over the treatment period. Outcomes will focus on changes in intestinal function and constipation-related symptoms compared between the probiotic and placebo groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or non-pregnant female subjects aged 18 to 65 who are willing to sign the informed consent form;
* Diagnosed with functional constipation as assessed by a physician;
* Non-pregnant females who agree to use physical contraceptive methods during the study period (e.g., condoms, intrauterine devices);
* No history of organ transplantation, epilepsy or seizures, liver or kidney disease, malignancy, psychiatric disorders, alcohol or drug abuse, or other major organic diseases (as determined by medical history).

Exclusion Criteria:

* Use of probiotics, gastrointestinal health supplements, medications, or antibiotics within 30 days prior to the study;
* Presence of chronic gastrointestinal diseases (e.g., irritable bowel syndrome \[IBS\], inflammatory bowel disease \[IBD\], Crohn's disease, celiac disease, bowel control problems/fecal incontinence, pancreatitis, peptic ulcers, colorectal cancer, short bowel syndrome, ulcerative colitis);
* History of gastrointestinal or major surgery;
* Lactose intolerance;
* Chronic diarrhea;
* Pregnant or breastfeeding women;
* Known allergy to any components of the study product.

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Jaw-Shiun Tsai, Doctor — National Taiwan University Hospital
• Study coordinator: Ping Lin, Ms.
• Email: candice.lin@tci-bio.com
• Phone: +886-87977811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Prebiotic and Probiotic Combo for Constipation Symptoms

  This study tests whether adding 1-kestose to a probiotic (BBH112) helps adults with constipation-related symptoms see more relief and better quality of life.

  Recruiting Seoul National University Hospital · Seongnam-si, Gyeonggi-do · NCT07923279

• Constipation Prevention Checklist in hip surgery patients

  A simple checklist is used to see if hip surgery patients can stay regular by staying hydrated, eating well, moving early, and using abdominal massage.

  Recruiting Cumhuriyet University · Sivas · NCT07895316

• Abdominal massage training for caregivers to help manage constipation

  Caregivers receive training to use abdominal massage and help their loved ones with constipation in palliative care to see if it improves symptoms and caregiver confidence.

  Recruiting Saglik Bilimleri Universitesi · Istanbul · NCT07886125

• Relationship between body awareness and posture in IBS-C patients compared with healthy people

  This study tests whether people with constipation-predominant IBS have different interoceptive awareness and posture compared with healthy controls.

  Recruiting Saglik Bilimleri Universitesi · Istanbul · NCT07870915

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.