Effects of Fermented Dairy Products on Defecation Changes Through Gut Microbiota

NCT06862310 | Completed DMC

• 2 other identifiers: lin5611_1A-109-082
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators recruited participants aged 20-65 years who did not have gastrointestinal diseases and who were not taking medication for digestive symptoms (e.g., gastric acid inhibitors, antibiotics, sterilization medications, or antidiarrheal agents) in the month before enrollment. The participants were prohibited from consuming any probiotic foods, supplements, or fermented dairy products except those that were provided during the 6-week study. Each participant first completed a 2-week adaptation period (n = 22). Subsequently, each participant was randomly assigned to either a control or intervention group. The participants received two 200-g daily servings of either a probiotic-infused fermented milk or a control dairy product for 4 weeks.

Conditions

Defecation Irregularity

Keywords

defecation; yogurt; Lactobacillus

Outcome Measures

Primary Outcomes (1)

• Defecation frequency per week

  defecation frequency per week was recorded by the participients

  From enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Participant feeling during defecation

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

acidified milk without adding beneficial bacteria

Other: yogurt intervention

yogurt intervention

EXPERIMENTAL

probiotic-enriched fermented milk (2.0 × 10⁹ Colony-forming unit \[CFU\]/mL)

Other: yogurt intervention

Interventions

yogurt intervention OTHER

daily probiotics dose of 3 × 108 CFU (95% confidence interval \[CI\]: 1 × 109 to 3 × 1010 CFU) in 112 mL of fermented milk per day (95% CI: 100-187.5 mL/day)

placebo; yogurt intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 20-65 years old
• without gastrointestinal diseases or other health problems
• agree not to consume antibiotics, health supplements that may affect the composition of intestinal flora (ex. probiotics, prebiotics), and fermented dairy products (ex. yogurt, cheese other than those provided in this experiment) during the experiment.

You may not qualify if:

• under pregnancy
• with gastrointestinal diseases or other health problems

Sponsors & Collaborators

• Taipei Medical University: lead
• Z-Plus Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 6, 2025
• Study Start: March 9, 2021
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

TW (1)