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Can a diet and lifestyle program replace acid reflux pills after achalasia surgery?

NCT ID NCT07620899

Disease control Sponsor: Asian Institute of Gastroenterology, India 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a structured program of dietary changes, lifestyle adjustments, and nutrient correction can reduce reflux symptoms in patients who had POEM surgery for achalasia. Many patients develop GERD after POEM and rely on long-term acid-reducing medications. The trial compares this program to standard care in 166 adults, with the goal of improving quality of life and reducing medication dependence.

What this could mean

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

Active substance
structured diet and lifestyle program (dietary counseling, micronutrient correction, H. pylori treatment, lifestyle optimization)
What this could lead to
If it works, this program could help many patients reduce or stop their acid-reducing medications and improve their quality of life after POEM surgery.
What could go wrong
This is a relatively small, early-stage trial (166 participants) testing a non-drug intervention, so results may not apply broadly. The program requires strict adherence, and some patients may not benefit or may still need medication.

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

About 166 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

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 70 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 for RCT * Above criteria plus AET\> 6% on pH impedance monitoring. * Adults aged 18-70 years. * Patients who stopped PPI/PCABs atleast 4 weeks prior to enrolment (to avoid false negative h.pylori test) * Prior POEM performed between 6 months and 5 years before enrolment at AIG hospitals. * Willingness to comply with lifestyle and nutritional interventions. * Ability to provide written informed consent. Inclusion Criteria for Observational Registry * Adults aged 18-70 years. * Prior POEM performed between 6 months and 5 years before enrolment, at AIG hospitals. * Clinically significant GERD symptoms after POEM. GERD-HRQL score ≥10, or * reflux symptoms occurring ≥3 times per week, or * current use of PPI/PCAB therapy for reflux symptom control * reflux esophagitis on endoscopy. * Unable to undergo ambulatory reflux monitoring due to logistical reasons, . * Ability to provide written informed consent. Exclusion criteria: * Prior oesophageal surgery other than POEM. * Severe comorbidities limiting life expectancy (\<2 years). * Pregnancy or lactation. * Active gastrointestinal malignancy. * Contraindication to PPI therapy. * Inability to provide informed consent or comply with follow-up.

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Conditions

The condition(s) this trial relates to.

Esophageal Achalasia gastroesophageal reflux disease idiopathic achalasia

As listed by the trial registrant

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

Achalasia cardia GERD (gastroesophageal reflux disease)

Contacts and locations

Locations

  • Asian Institute of Gastroenterology

    Hyderabad, Telangana, 500032, India

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