Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy

NCT07291700 | Recruiting

• 1 other identifier: 22800
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study aims to explore the effectiveness of hydrotalcite, marketed as Talcid, in alleviating acid-related symptoms that occur due to an acid rebound after discontinuing a non-/no-longer-indicated long-term proton pump inhibitor (PPI) therapy. PPIs are commonly prescribed to reduce stomach acid to alleviate symptoms such as heartburn and for the treatment of, for example, duodenal and stomach ulcers. Discontinuation after prolonged use can lead to a rebound effect where dyspeptic complaints such as heartburn occur once the medication is stopped. This study is conducted in Germany and involves adult participants who have stopped using non-/no-longer-indicated PPIs and are experiencing these rebound symptoms. Hydrotalcite is recommended by physicians as an on-demand treatment for managing acid-related symptoms. The study seeks to gather real-world evidence on its effectiveness, consumer experience, and acceptance to support claims about its use to relieve acid related symptoms due to an acid rebound. Participants will use hydrotalcite as needed (on demand when symptoms occur) over a four-week period, and will record information about symptom relief, the time it takes for relief to occur, and overall satisfaction with the treatment. Additionally, their doctors rate the suitability, tolerability, and effectiveness of the treatment. The primary objective of the study is to assess the effectiveness of hydrotalcite by the number and percentage of patients not having used PPIs during the study period. Secondary objectives include evaluating relief from specific symptoms (heartburn, reflux, epigastric pain, feeling of fullness, and nausea, as well as improvements in quality of life due to hydrotalcite treatment. The study will also assess participants' satisfaction with hydrotalcite as an on-demand treatment and its suitability for managing these symptoms. Participants will be adults aged 18 and older who have discontinued a long-term PPI therapy (≥8 weeks) for which there is no current indication according to indication and guidelines and who are experiencing acid rebound symptoms after stopping the PPI therapy. The study will exclude individuals with endoscopically diagnosed gastroesophageal reflux disease (GERD) (LA grade C/ D esophagitis) or those with hydrotalcite contraindications or warnings, such as pregnancy, severe renal impairment, or allergies to its ingredients. Data will be collected through standardized questionnaires completed by participants after they consent to join the study. The study aims to enroll approximately 167 participants, anticipating a 40% drop-out rate, to ensure around 100 completed questionnaires. Statistical analyses will be exploratory and descriptive, focusing on categorical and continuous variables. The study is designed to be observational, meaning there will be no direct intervention or randomization of participants. Instead, it will collect primary data directly from participants and investigators across approximately twenty sites in Germany. The results will provide valuable insights into the effectiveness of hydrotalcite in managing acid rebound symptoms and may inform future treatment recommendations for participants discontinuing long-term PPI therapy.

Conditions

Gastroesophageal Reflux

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number and percentage of subjects successfully discontinued proton pump inhibitor (PPI) therapy defined as no intake of PPI within a period of 4 weeks after start of treatment

  Number and percentage of subjects successfully discontinued PPI therapy defined as no intake of PPI within a period of 4 weeks after start of hydrotalcite (500 mg Talcid chewable tablets) as on-demand treatment to treat symptoms due to acid-rebound.

  4 weeks

Secondary Outcomes (8)

• Score (5-point rating scale) of overall relief from acid-related symptoms due to an acid rebound when used as an on-demand treatment

  Daily during 4-week treatment period

• Number and percentage of subjects satisfied with hydrotalcite (Talcid® Chewable Tablets) as an on-demand treatment for treating their acid-related symptoms due to an acid-rebound

  once at the end of the 4-week treatment period

• Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being suitable as an on-demand treatment for treating acid-related symptoms due to an acid-rebound

  once at final data collection timepoint at the end of the 4-week treatment period

• Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being well tolerated as an on-demand treatment for treating acid-related symptoms due to an acid-rebound

  once at final data collection timepoint at the end of the 4-week treatment period

• Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being effective as an on-demand treatment for treating acid-related symptoms due to an acid-rebound

  once at final data collection timepoint at the end of the 4-week treatment period

Study Arms (1)

Group 1

Talcid (hydrotalcite) 500mg chewable tablet

Drug: Hydrotalcite (Talcid, BAYX002833)

Interventions

Hydrotalcite (Talcid, BAYX002833) DRUG

Talcid Chewable Tablet (500 mg hydrotalcite) taken on-demand for acid-related symptoms.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects aged 18 years and older for whom there is not/no longer an indication for a daily PPI therapy according to approval status and guidelines, and who suffer from acid related symptoms due to an acid rebound after discontinuation of a non/no longer indicated long-term PPI-therapy (≥8 weeks).

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Bayer Vital GmbH

Leverkusen, 51373, Germany

RECRUITING

Bayer Germany

Wuppertal, 42096, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Nausea

Interventions

hydrotalcite

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 18, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)