Hydrotalcite (Talcid) for relief of rebound acid symptoms after stopping long-term PPI therapy

A Non-Interventional Study to Investigate the Effectiveness of Hydrotalcite to Relieve Acid-Related Symptoms Due to an Acid Rebound After Discontinuation of a Non/No Longer Indicated Long-Term PPI Therapy.

We are trying hydrotalcite (Talcid) to see if it relieves rebound acid symptoms in adults who have stopped long-term PPI treatment.

Quick facts

• Study type: Observational
• Enrollment: 167 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bayer (industry)
• Locations: 2 sites (Leverkusen and 1 other locations)
• Trial ID: NCT07291700 on ClinicalTrials.gov

What this trial studies

This observational program collects real-world data from adults in Germany who discontinued long-term proton pump inhibitor therapy and now experience rebound acid symptoms. Participants will use hydrotalcite (Talcid) on demand while investigators record symptom relief, user experience, and acceptance. The approach relies on routine use rather than experimental dosing, with information gathered through patient reports and site follow-up. The aim is to describe how well hydrotalcite manages post-PPI dyspeptic complaints in everyday clinical practice.

Who should consider this trial

Good fit: Adults (≥18) who stopped daily PPI therapy after at least 8 weeks without a current guideline-based indication, are experiencing acid rebound symptoms, have no endoscopically diagnosed GERD, and have no current indication for PPI therapy.

Not a fit: Patients with moderate-to-severe reflux esophagitis, gastric or duodenal ulcers, confirmed Helicobacter pylori infection, or any condition that still requires ongoing PPI therapy are unlikely to benefit from this on-demand treatment.

Why it matters

Potential benefit: If successful, hydrotalcite could provide quick on-demand relief of rebound heartburn and related acid symptoms and reduce the need to restart PPI therapy.

How similar studies have performed: Antacids including hydrotalcite are commonly used and recommended for symptom relief, but rigorous clinical evidence specifically targeting PPI rebound phenomena is limited.

Eligibility criteria

Eligibility Criteria:

Adult female or male subjects aged ≥ 18

* Subjects who have discontinued daily PPI therapy (≥ 8 weeks of therapy) for which there is no current indication according to guidelines and approval status, e.g.

  * irritable bowel syndrome
  * subjects who receive Non-Steroidal Anti-Inflammatory drug (NSAID) treatment with no warning signals\* regarding ulcers
  * polymedication\*\* with no warning signals\* or side effects regarding ulcers
  * unclarified upper abdominal discomfort
  * mild forms of GERD; like Non-Erosive Reflux Disease (NERD), Los Angeles (LA) grade A/B esophagitis
* Suffer from acid-rebound due to a discontinuation of a non/no longer indicated long-term PPI therapy (≥ 8 weeks of therapy)
* No endoscopically diagnosed GERD\*\*\*
* No indication for a PPI-therapy according to guidelines.

Examples for guideline recommendations for a PPI-therapy:

* moderate - severe forms of reflux esophagitis
* gastric ulcer, duodenal ulcer
* Helicobacter pylori eradication
* moderate/severe forms of GERD - Los Angeles (LA) grade C/D esophagitis
* Zollinger-Ellison-Syndrome

No Talcid® contraindications or warnings as:

* pregnancy and lactation
* severe renal impairment
* hypophosphatemia
* existing myasthenia gravis
* impaired renal function
* Alzheimer's disease or other forms of dementia
* patients under low-phosphate diet
* hypersensitivity to the ingredients of Talcid®

  * Subjects who voluntarily agree to use Talcid® Chewable Tablets for relief of acid-related symptoms due to acid-rebound
  * Decision to initiate on-demand treatment of acid-related symptoms due to acid-rebound with Talcid® was made as per investigator's routine recommendation practice and by the subject
  * Subject purchases Talcid® for her/his own use
  * Signed informed consent
  * No participation in an investigational program with interventions outside of routine clinical practice
  * No contraindications according to the local marketing authorization

    \* Warning signals:
  * Age \> 60 (with one additional warning signal)
  * Previous history or family history of ulcers
  * Helicobacter pylori positive status \*\* Polymedication: defined as at least five medicinal products at the same time for a continuous therapy \*\*\* Endoscopy: LA grade C/ D esophagitis, Barrett esophagus, peptic stricture; pH- Impedance measurement: acid exposure \> 6%

Exclusion Criteria: not applicable

Where this trial is running

Leverkusen and 1 other locations

• Bayer Vital GmbH — Leverkusen, Germany (RECRUITING)
• Bayer Germany — Wuppertal, Germany (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions: Gastroesophageal Reflux, Heartburn,, Gastroesophageal Reflux,, Nausea,, Epigastric Pain,, Feeling of Fullness,, Acid-related Symptoms,, Acid Rebound