Gastroesophageal RefluxNCT05283447
Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia
A study testing Osteopathic Medicine in people with Gastroesophageal Reflux, run by Escoles Universitaries Gimbernat at 1 site in Spain.
Trial summary
Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients' clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Osteopathic Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Gastroesophageal Reflux disease (Vakil et al, 2006)
- Age between 18 and 90 years.
- Patients with GERD due to hiatal hernia type I, without surgical indication.
- Patients with GERD due to hiatal hernia type I, with surgical indication on the waiting list.
- Patients with GERD due to hiatal hernia type I, with surgical contraindication.
Who cannot join
- That fail to meet inclusion criteria.
- Patients treated with Benzodiazepines (BZD)
- Patients with previous surgical interventions at the abdominal level, especially of supramesocolic structures
- Patients diagnosed with Barrett's esophagus
- Patients with paraesophageal and mixed hiatus hernias
- Diagnosed erosive esophagitis
Show all 14Show fewer
- Active neoplasm
- Serious psychiatric disorders
- Neuromuscular or neurological injuries
- Aneurysms
- Pregnancy
- Hemophilia or treatment with anticoagulant therapy
- Hypersensitivity of the skin or dermatological diseases in the trunk that prevent the performance of the techniques
- Rejection of manual contact
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy in the Treatment of Gastroesophageal Reflux Disease in Patients With Type I Hiatal Hernia
Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients' clinic. Pharmacological treatment with proton pump inhibitors (IBPs) and H2 blockers is commonly prescribed and will be followed for many patients for life. The cost of health care and the effects of prolonged consumption of PPIs are questionable, and other therapeutic alternatives are being considered. Only in exceptional cases and in patients with GERD and certain types of hiatal hernia is surgery the treatment of choice. Physiotherapy at the time proposed respiratory and diaphragmatic training as a therapeutic alternative that would improve the function of anti-reflux barriers. Recently, other studies evaluating the effectiveness of manual techniques on the crural diaphragm or osteopathic maneuvers on the cervical and thoracic region have obtained good results in the improvement of the MRGE clinic. In this context, the clinical trial presented specifically treats those with reflux disease associated with a Type I hiatal hernia with manual therapy.
Material and methods: The aim of the clinical study is to evaluate the effects of a clinical intervention protocol on patients with GERD for type I hiatal hernia.
Read more
The variables are assessed: GERD impact using the GIS MRG Impact Scale, and the EVA format scale for the Reflux Clinic (IEPT) used by the Surgery Service of the Parc Taulí Hospital in Sabadell . The productivity and quality of life of these patients is also assessed using the QOLRAD reflux and dyspepsia patient quality of life questionnaire.
The randomized, double-blind clinical trial has a sample of 44 patients, divided into an intervention group treated with the protocol under study, and a control group undergoing treatment that does not affect the hernia. hiatus and reflux. A total of three treatment sessions are performed on each subject. The participants answer the different questionnaires, before the start of the treatment and for each session, one week after the treatment and one month later. In the protocol, maneuvers are performed on the epigastric region, thoracic diaphragm, mediastinum and anterior face of the neck.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Osteopathic Medicine, Control
- Keywords
- Hernia, Hiatal, Osteopathic Medicine, Musculoskeletal Manipulations, Gastroesophageal Reflux
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic MedicineOther
The clinical protocol subject to analysis for the intervention group consists of manual approach techniques for the myofascial and viscerofascial structures of the anterior face of the neck, maneuvers for the mediastinal region, techniques for normalizing the tone of the thoracic diaphragm and its pillars, on the peritoneal ligaments, and caudal traction of the stomach for manual correction of hiatal hernia.
ControlOther
The physiotherapeutic treatment on the control group consists of an approach to the lumbopelvic joint restrictions and a massage on the inframesocolic abdominal region with minimal pressure, which does not affect the activity and position of the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Specific manual therapy for GERD and hiatal hernia Receives: Other: Osteopathic Medicine |
| Control | Placebo comparator | Manual therapy unrelated to GERD and hiatal hernia Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of GERD (Gastro-oesophageal Reflux Disease)
Using "The Gastro-oesophageal Reflux Disease Impact scale" (GIS).The GIS impact assessment scale consists of 9 items that refer to the frequency during the last week of 5 possible symptoms of GERD, the impact on sleep, food or drink intake, work or activities of daily living and the need to use medications in addition to those prescribed by your doctor (from "daily" to "never" on a 4-point Likert-type scale). The Gis scale score ranges from 1 to 4, the higher the score, the better the patient's condition. The scale was validated in Spanish in 2008. (New, Tafalla et al, 2008).
Measured: 8 weeks
Secondary outcomes (2)
Impact of GERD (Gastro-oesophageal Reflux Disease)
Using the "Gastro-oesophageal Reflux Disease impact assessment scale" used by gastroenterology team of the CSPT (Corporación Sanitaria Parc Taulí), aims to objectify GERD symptoms using a 0-10 range. The symptoms generated exclusively by the Reflux will be chosen: heartburn, regurgitation, cough, aphonia, epigastralgia. The maximum sum of the items on the scale is 50 points, indicating maximum severity. The value 0 points would indicate a minimal impact of the disease.
Measured: 8 weeks
Quality of life in patients with GERD
For the collection of specific data on the quality of life of the patients, the QOLRAD scale will be used, this scale contains 25 items, in which the patient is asked about the effect of gastrointestinal symptoms on quality of life. Establishing the relationship with: emotional well-being, sleep, vitality, food and drink, and physical/social functioning. The patient answers the questionnaire about the frequency of these effects in relation to the last week, using a 7-point Likert scale ranging from "all the time/very much" to "never/not at all". Low scores indicate significant impairment in daily functioning (Kulich KR et al, 2005)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start15 May 2022
- Primary completion16 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Principal investigator, Ricard Tutusaus, Escoles Universitaries Gimbernat
- Investigators
- Ricard Tutusaus Homs, MSc, Principal investigator, EU GimbernatSalvador Navarro Soto, PhD, Study director, Corporación Parc TaulíAlexis Luna Aufroy, PhD, Study director, Corporación Parc TaulíJosep Maria Potau Ginés, Study director, Universidad de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283447
- Sponsor's protocol ID
- 2018308
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The pandemic has delayed the completion of the study and no publication date for the information has been proposed.
Publications
El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
PubMed 23853213Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PubMed 16928254Dean C, Etienne D, Carpentier B, Gielecki J, Tubbs RS, Loukas M. Hiatal hernias. Surg Radiol Anat. 2012 May;34(4):291-9. doi: 10.1007/s00276-011-0904-9. Epub 2011 Nov 22.
PubMed 22105688Bresadola V, Noce L, Ventroni MG, Vianello V, Intini S, Bresadola F. [Sliding hiatal hernia in patients with gastroesophageal reflux: physiopathology and surgical treatment]. Minerva Chir. 2000 Jun;55(6):415-20. Italian.
PubMed 11059235Savas N, Dagli U, Sahin B. The effect of hiatal hernia on gastroesophageal reflux disease and influence on proximal and distal esophageal reflux. Dig Dis Sci. 2008 Sep;53(9):2380-6. doi: 10.1007/s10620-007-0158-x. Epub 2008 Jan 17.
PubMed 18205046Puri R, Sharma S. Hiatal Hernia. 2026 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562200/
PubMed 32965871Patti MG, Goldberg HI, Arcerito M, Bortolasi L, Tong J, Way LW. Hiatal hernia size affects lower esophageal sphincter function, esophageal acid exposure, and the degree of mucosal injury. Am J Surg. 1996 Jan;171(1):182-6. doi: 10.1016/S0002-9610(99)80096-8.
PubMed 8554137Gryglewski A, Pena IZ, Tomaszewski KA, Walocha JA. Unsolved questions regarding the role of esophageal hiatus anatomy in the development of esophageal hiatal hernias. Adv Clin Exp Med. 2014 Jul-Aug;23(4):639-44. doi: 10.17219/acem/37247.
PubMed 25166451Yu HX, Han CS, Xue JR, Han ZF, Xin H. Esophageal hiatal hernia: risk, diagnosis and management. Expert Rev Gastroenterol Hepatol. 2018 Apr;12(4):319-329. doi: 10.1080/17474124.2018.1441711. Epub 2018 Feb 22.
PubMed 29451037Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
PubMed 23419381Wu AH, Tseng CC, Bernstein L. Hiatal hernia, reflux symptoms, body size, and risk of esophageal and gastric adenocarcinoma. Cancer. 2003 Sep 1;98(5):940-8. doi: 10.1002/cncr.11568.
PubMed 12942560de Burgos Lunar C, Novo del Castillo S, Llorente Diaz E, Salinero Fort MA. [Study of prescription-indication of proton pump inhibitors]. Rev Clin Esp. 2006 Jun;206(6):266-70. doi: 10.1157/13088585. Spanish.
PubMed 16762289Aguilera-Castro L, Martin-de-Argila-dePrados C, Albillos-Martinez A. Practical considerations in the management of proton-pump inhibitors. Rev Esp Enferm Dig. 2016 Mar;108(3):145-53. doi: 10.17235/reed.2015.3812/2015.
PubMed 26666270Lopez-Doriga Bonnardeaux P, Neira Alvarez M, Mansilla Laguia S. [Proton bomb inhibitors: a study of the prescription in a functional recovery unit]. Rev Esp Geriatr Gerontol. 2013 Nov-Dec;48(6):269-71. doi: 10.1016/j.regg.2013.07.004. Epub 2013 Oct 5. Spanish.
PubMed 24099902de la Coba Ortiz C, Arguelles Arias F, Martin de Argila de Prados C, Judez Gutierrez J, Linares Rodriguez A, Ortega Alonso A, Rodriguez de Santiago E, Rodriguez-Tellez M, Vera Mendoza MI, Aguilera Castro L, Alvarez Sanchez A, Andrade Bellido RJ, Bao Perez F, Castro Fernandez M, Giganto Tome F. Proton-pump inhibitors adverse effects: a review of the evidence and position statement by the Sociedad Espanola de Patologia Digestiva. Rev Esp Enferm Dig. 2016 Apr;108(4):207-24. doi: 10.17235/reed.2016.4232/2016.
PubMed 27034082
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy in the Treatment of Gastroesophageal Reflux Disease in Patients With Type I Hiatal Hernia
- ClinicalTrials.gov ID
- NCT05283447
- Acronym / sponsor ID
- 2018308
- Conditions
- Gastroesophageal Reflux
- Keywords
- Hernia, Hiatal, Osteopathic Medicine, Musculoskeletal Manipulations, Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- 15 May 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients' clinic. Pharmacological treatment with proton pump inhibitors (IBPs) and H2 blockers is commonly prescribed and will be followed for many patients for life. The cost of health care and the effects of prolonged consumption of PPIs are questionable, and other therapeutic alternatives are being considered. Only in exceptional cases and in patients with GERD and certain types of hiatal hernia is surgery the treatment of choice. Physiotherapy at the time proposed respiratory and diaphragmatic training as a therapeutic alternative that would improve the function of anti-reflux barriers. Recently, other studies evaluating the effectiveness of manual techniques on the crural diaphragm or osteopathic maneuvers on the cervical and thoracic region have obtained good results in the improvement of the MRGE clinic. In this context, the clinical trial presented specifically treats those with reflux disease associated with a Type I hiatal hernia with manual therapy.
Material and methods: The aim of the clinical study is to evaluate the effects of a clinical intervention protocol on patients with GERD for type I hiatal hernia.
The variables are assessed: GERD impact using the GIS MRG Impact Scale, and the EVA format scale for the Reflux Clinic (IEPT) used by the Surgery Service of the Parc Taulí Hospital in Sabadell . The productivity and quality of life of these patients is also assessed using the QOLRAD reflux and dyspepsia patient quality of life questionnaire.
The randomized, double-blind clinical trial has a sample of 44 patients, divided into an intervention group treated with the protocol under study, and a control group undergoing treatment that does not affect the hernia. hiatus and reflux. A total of three treatment sessions are performed on each subject. The participants answer the different questionnaires, before the start of the treatment and for each session, one week after the treatment and one month later. In the protocol, maneuvers are performed on the epigastric region, thoracic diaphragm, mediastinum and anterior face of the neck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Osteopathic MedicineSpecific manual therapy for GERD and hiatal hernia |
| Control | Placebo comparator | Other: ControlManual therapy unrelated to GERD and hiatal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Gastroesophageal Reflux disease (Vakil et al, 2006)
- Age between 18 and 90 years.
- Patients with GERD due to hiatal hernia type I, without surgical indication.
- Patients with GERD due to hiatal hernia type I, with surgical indication on the waiting list.
- Patients with GERD due to hiatal hernia type I, with surgical contraindication.
Key exclusion criteria (14 listed)
- That fail to meet inclusion criteria.
- Patients treated with Benzodiazepines (BZD)
- Patients with previous surgical interventions at the abdominal level, especially of supramesocolic structures
- Patients diagnosed with Barrett's esophagus
- Patients with paraesophageal and mixed hiatus hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic MedicineThe clinical protocol subject to analysis for the intervention group consists of manual approach techniques for the myofascial and viscerofascial structures of the anterior face of the neck, maneuvers for the mediastinal region, techniques for normalizing the tone of the thoracic diaphragm and its pillars, on the peritoneal ligaments, and caudal traction of the stomach for manual correction of hiatal hernia. | Other | Intervention |
| ControlThe physiotherapeutic treatment on the control group consists of an approach to the lumbopelvic joint restrictions and a massage on the inframesocolic abdominal region with minimal pressure, which does not affect the activity and position of the stomach. | Other | Control |
Primary outcome
Impact of GERD (Gastro-oesophageal Reflux Disease)
Time frame: 8 weeks
Using "The Gastro-oesophageal Reflux Disease Impact scale" (GIS).The GIS impact assessment scale consists of 9 items that refer to the frequency during the last week of 5 possible symptoms of GERD, the impact on sleep, food or drink intake, work or activities of daily living and the need to use medications in addition to those prescribed by your doctor (from "daily" to "never" on a 4-point Likert-type scale). The Gis scale score ranges from 1 to 4, the higher the score, the better the patient's condition. The scale was validated in Spanish in 2008. (New, Tafalla et al, 2008).
2 secondary outcomes
Impact of GERD (Gastro-oesophageal Reflux Disease)
Time frame: 8 weeks
Quality of life in patients with GERD
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 23853213El-Serag HB, Sweet S, Winchester CC, Dent J. Update on the epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2014 Jun;63(6):871-80. doi: 10.1136/gutjnl-2012-304269. Epub 2013 Jul 13.
- Background: PubMed 16928254Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Background: PubMed 22105688Dean C, Etienne D, Carpentier B, Gielecki J, Tubbs RS, Loukas M. Hiatal hernias. Surg Radiol Anat. 2012 May;34(4):291-9. doi: 10.1007/s00276-011-0904-9. Epub 2011 Nov 22.
- Background: PubMed 11059235Bresadola V, Noce L, Ventroni MG, Vianello V, Intini S, Bresadola F. [Sliding hiatal hernia in patients with gastroesophageal reflux: physiopathology and surgical treatment]. Minerva Chir. 2000 Jun;55(6):415-20. Italian.
- Background: PubMed 18205046Savas N, Dagli U, Sahin B. The effect of hiatal hernia on gastroesophageal reflux disease and influence on proximal and distal esophageal reflux. Dig Dis Sci. 2008 Sep;53(9):2380-6. doi: 10.1007/s10620-007-0158-x. Epub 2008 Jan 17.
- Background: PubMed 32965871Puri R, Sharma S. Hiatal Hernia. 2026 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562200/
- Background: PubMed 8554137Patti MG, Goldberg HI, Arcerito M, Bortolasi L, Tong J, Way LW. Hiatal hernia size affects lower esophageal sphincter function, esophageal acid exposure, and the degree of mucosal injury. Am J Surg. 1996 Jan;171(1):182-6. doi: 10.1016/S0002-9610(99)80096-8.
- Background: PubMed 25166451Gryglewski A, Pena IZ, Tomaszewski KA, Walocha JA. Unsolved questions regarding the role of esophageal hiatus anatomy in the development of esophageal hiatal hernias. Adv Clin Exp Med. 2014 Jul-Aug;23(4):639-44. doi: 10.17219/acem/37247.
- Background: PubMed 29451037Yu HX, Han CS, Xue JR, Han ZF, Xin H. Esophageal hiatal hernia: risk, diagnosis and management. Expert Rev Gastroenterol Hepatol. 2018 Apr;12(4):319-329. doi: 10.1080/17474124.2018.1441711. Epub 2018 Feb 22.
- Background: PubMed 23419381Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
- Background: PubMed 12942560Wu AH, Tseng CC, Bernstein L. Hiatal hernia, reflux symptoms, body size, and risk of esophageal and gastric adenocarcinoma. Cancer. 2003 Sep 1;98(5):940-8. doi: 10.1002/cncr.11568.
- Background: PubMed 16762289de Burgos Lunar C, Novo del Castillo S, Llorente Diaz E, Salinero Fort MA. [Study of prescription-indication of proton pump inhibitors]. Rev Clin Esp. 2006 Jun;206(6):266-70. doi: 10.1157/13088585. Spanish.
- Individual participant dataSharing planned: Undecided. The pandemic has delayed the completion of the study and no publication date for the information has been proposed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricard Tutusaus Homs, MSc principal investigator
EU Gimbernat
Salvador Navarro Soto, PhD study director
Corporación Parc Taulí
Alexis Luna Aufroy, PhD study director
Corporación Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Medicine in people with Gastroesophageal Reflux, run by Escoles Universitaries Gimbernat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of GERD (Gastro-oesophageal Reflux Disease) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283447, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.