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Herbal blend and probiotics: a new hope for stubborn constipation?

NCT ID NCT07757061

Disease control Sponsor: First People's Hospital Of Lin'an District, Hangzhou Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This trial tests whether combining a 12-herb traditional Chinese medicine formula with plant-derived probiotics can improve symptoms of slow transit constipation, a condition where the colon moves stool too slowly. About 120 adults with this condition will be randomly assigned to receive the herbal formula plus probiotics, either alone or with a standard prokinetic drug, or the drug alone for 8 weeks. Researchers will measure changes in constipation severity, quality of life, and how quickly stool moves through the colon, and will track relapse over 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A traditional Chinese herbal formula (Yìqì Jiànpí Decoction) combined with plant-derived Lactobacillus probiotics
What this could lead to
If effective, this combination could offer a more durable, natural option for people with slow transit constipation, potentially reducing relapse after stopping treatment.
What could go wrong
This is an early-stage trial with a modest sample size, and results may not generalize. Herbal formulas can vary in quality, and probiotics may cause mild digestive upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

Jan 2025

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Meeting the Rome IV criteria for functional constipation, with predominant slow transit type confirmed by a colon transit study (retention of ≥20% of markers at 72 hours). 2. Age between 18 and 75 years. 3. Ability to comply with study procedures and provide written informed consent. 4. No use of antibiotics, probiotics, or other laxatives (except rescue) within 2 weeks before enrollment. Exclusion Criteria: 1. Outlet obstruction constipation (confirmed by anorectal manometry or defecography). 2. Secondary constipation due to organic diseases (e.g., colorectal cancer, inflammatory bowel disease). 3. History of abdominal surgery (except appendectomy or cholecystectomy). 4. Severe systemic illness (e.g., heart failure, renal failure, liver cirrhosis). 5. Pregnancy or lactation. 6. Known allergy to any herbal ingredient or Lactobacillus preparation. 7. Use of medications affecting gastrointestinal motility (e.g., opioids, anticholinergics) within 4 weeks before screening.

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Conditions

The condition(s) this trial relates to.

constipation disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation Slow transit constipation

Contacts and locations

Locations

  • Department of Colorectal Surgery, The First People's Hospital of Lin'an District, Hangzhou

    Hangzhou, Zhejiang, 311300, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.