Gastro-oesophageal Reflux Disease Trial, Recruiting NCT07121803 Sponsor: Federal State Budgetary Scientific Institution Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT07121803
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing to take part and have signed a written consent form
  • People whose blood sugar levels are stable and well-controlled
  • People whose diabetes treatment (such as metformin, certain tablets, or insulin) has not changed — including no new medications added — in the 6 months before joining
  • People whose diabetes medication doses have remained the same for at least 6 months before joining
  • People who agree not to start any new medications during the study

Who may not be able to join:

  • People who are pregnant or breastfeeding
  • People with liver cirrhosis, as confirmed by liver biopsy, a liver stiffness scan result of 14 kPa or higher, or certain liver blood test scores above set thresholds
  • People who have frequent watery diarrhoea (more than 3 loose stools per day)
  • People with chronic heart failure, at any stage of severity
  • People who have had major surgery on the abdomen or chest in the past, including weight-loss surgery or reflux surgery (though appendix or gallbladder removal more than one year before joining may be acceptable — confirm with trial site)
  • People with certain swallowing disorders affecting the oesophagus or the junction between the oesophagus and stomach (confirm with trial site)
  • People with major oesophageal movement disorders as classified under a specific medical classification system (confirm with trial site)
  • People who have had a serious heart or cardiovascular event in the 6 months before the screening visit
  • People with high blood pressure that remains uncontrolled despite treatment
  • People with Type 1 diabetes
  • People whose HbA1c (a measure of long-term blood sugar control) is above 9.0%
  • People with a known allergy or sensitivity to the study product or any of its ingredients, including lactose intolerance
  • People currently taking certain medications known to affect how the oesophagus moves, such as some blood pressure medications, muscle relaxants, antidepressants, or similar drugs
  • People with any condition that may significantly affect life expectancy, including known cancers
  • People with significant immune, hormonal, blood, digestive, neurological, tumour, or psychiatric conditions
  • People whose mental health or capacity may affect their ability to consent, take part, or follow the study requirements
  • People who are unable to tolerate a specific oesophageal test procedure (high-resolution manometry) without sedation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Sergey Morozov, MD, PhD, Federal Research Center of Nutrition and Biotechnology

Phone: 4996131091

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Federal State Budgetary Scientific Institution
Registry
ClinicalTrials.gov
Start date
1 July 2025
Est. completion
31 October 2025

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Mean lower esophageal sphincter resting pressure; Distal contractile integral; mean lower esophageal sphincter integral relaxation pressure; Mean contractile front velocity; Distal latency; Mean intrabolus pressure

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov