Functional Gastrointestinal DisordersNCT05209646
Bee Honey and Functional Dyspepsia in Children
A study testing Bee honey in people with Functional Gastrointestinal Disorders, run by Ain Shams University at 1 site in Egypt.
Trial summary
Functional dyspepsia is a constellation of diverse gastrointestinal disturbing symptoms with multifactorial feature, varying from upper abdominal bloating to nausea and vomiting, that are not attributable to organic causes after proper medical assessment. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Bee honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2022to 1 Jul 2022
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients between 8 and 18 years-old, based on Rome IV criteria that provide evidence-based definitions and classifications for so-called functional gastrointestinal disorders, such as functional dyspepsia in children and adolescents, with 1 or more of the following bothersome symptoms at least 4 days per month for at least 2 months:
- Postprandial fullness
- Early satiation
- Epigastric pain or burning not associated with defecation
- After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
- Postprandial distress syndrome includes bothersome postprandial fullness or early satiation that prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching.
- Epigastric pain syndrome, which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component and (b) the pain commonly induced or relieved by ingestion of a meal but may occur while fasting.
Who cannot join
- The presence of alarm symptoms and signs which might suggest underlying organic pathology as listed in Rome III criteria including: (Persistent right upper or right lower quadrant pain, dysphagia, persistent vomiting, gastrointestinal blood loss, nocturnal diarrhea, family history of inflammatory bowel disease, celiac disease, or peptic ulcer disease, pain that wakes the child from sleep, arthritis, perirectal disease, involuntary weight loss, deceleration of linear growth, delayed puberty or unexplained fever).
- Gastrointestinal tract surgery, one year post-operative.
- Diabetes mellitus
- Any debilitating disorder e.g. malignancy, severe malnutrition, renal failure, etc.
- Patients on medications that may produce GIT disorders e.g. aspirin, steroids or NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bee Honey as a Therapeutic Modality for Children With Functional Dyspepsia
Functional dyspepsia is a constellation of diverse gastrointestinal disturbing symptoms with multifactorial feature, varying from upper abdominal bloating to nausea and vomiting, that are not attributable to organic causes after proper medical assessment. Treatment options are unsatisfactory due to the lack of identifiable pathophysiology as well as the pharmacological therapy are less effective, so using an additional reliable non-pharmacological therapy would be promising.
Bee honey has not only being used as food but also it has being used as an alternative medicine for its several benefits in different health aspects. This study will address the use of bee honey as an adjuvant therapy to functional dyspepsia in children under proper follow-up periods.
Read the detailed description
Functional dyspepsia (FD), among the most common gastrointestinal (GIT) disorders, is characterized by early satiation, postprandial fullness, epigastric pain, or epigastric burning in the absence of an organic or metabolic disease. FD is not a life-threatening serious illness, but its symptoms could persist; rather, they limit one's social life and reduce their quality of life. In addition, FD constitutes a serious disease burden worldwide because of its high prevalence.
Proton pump inhibitor (PPI) in the form of Omeprazole had the best result on all dyspeptic symptoms being relieved on children aged 3-18 years with dyspepsia.
Nonetheless, the efficacy of pharmacological therapies remains unsatisfactory and a considerable number of FD patients are refractory to conventional pharmacological treatments. Furthermore, low compliance of the traditional therapy can be observed in some FD patients as they would opt out from these pharmacological options because of the concerns on the side effects. In the absence of an approved drug to treat FD many patients seek person-centered, nonpharmacological approaches.
As the consumption of nutrients can moderate the sensors of the upper gastrointestinal tract movement, changes in diet can probably improve the symptoms of functional dyspepsia. Alternative and complementary medicine has also been proposed as a practical treatment for dyspepsia. Another substance used for treating this disorder is honey, which is economical and has a short treatment period. Many old sources have reported the use of honey for preventing stomach ulcers, gastritis, and gastroenteritis. Honey has a stimulating effect on the stomach nerves, which may be due to the antioxidant activity of honey. According to a study, the consumption of honey reduces the acidic activity of the stomach by 56%. Another study showed the effect of honey on the improved blood supply of stomach microscopic capillaries and it helped in the repair of ulcers. The symptoms of functional dyspepsia can also be improved through diet education. In various studies, most people have reported the onset or exacerbation of dyspepsia symptoms after eating. Unhealthy nutritional behaviors can exacerbate the symptoms of functional dyspepsia.
Adjuvant supplementation of honey based formulation of Nigella sativa can cause significant symptomatic improvement of patients with functional dyspepsia.
Honey is considered one of the most common foods having alleviating effects on non-ulcer dyspepsia.
In considerations of scarce knowledge in this field, health attributes of bee honey as a reliable therapy to improve the symptoms of functional dyspepsia in children, deserves seeking for.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Bee honey
- Keywords
- Functional dyspepsia in children, Bee honey
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee honeyDietary supplement
patients will receive honey for 8 weeks in a dose of 30 ml undiluted honey per day divided as 5 ml honey 30 minutes before each meal six times daily. The honey will be kept in a closed glass container and away from light until the time of use. Each patient will be provided with a well-sealed container containing 210 ml honey each week. The honey used in the study will be a raw, unprocessed Clover honey collected from AL Mahala-Gharbia governorate, Egypt. The honey will be supplied directly from a beekeeper without heating or gamma irradiation.
| Study group | Role | What they receive |
|---|---|---|
| Trial (Intervention) group | Experimental | Patients will receive honey for 8 weeks in a dose of 30 ml undiluted honey per day divided as 5 ml honey 30 minutes before each meal six times daily. The honey will be kept in a closed glass container and away from light until the time of use. Each patient will be provided with a well-sealed container containing 210 ml honey each week. The honey used in the study will be a raw, unprocessed Clover honey collected from AL Mahala-Gharbia governorate, Egypt. The honey will be supplied directly from a beekeeper without heating or gamma irradiation Receives: Dietary Supplement: Bee honey |
| Control (Non-intervention) group | No intervention | No honey will be given to this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of bee honey on functional dyspepsia as an adjuvant therapy among dyspepsia suffering children assessed by Modified Glasgow Dyspepsia Severity Score in comparison to age and sex matched controls.
- Every week during the first 4 weeks of the study. Patients' response will be divided into complete recovery, partial improvement, no improvement or worsening of symptoms. At the 4th week of the study, those who completely recovered or partially improved will discontinue using PPI, while those with no improvement or worsening will continue on PPI and will be excluded
- At the 8th week of the study, honey will be discontinued and reassessment will be done
- Assessment of the severity of dyspepsia using "Modified Glasgow Dyspepsia Severity Score". It will be tried to evaluate the frequency of abdominal pain (predominant symptom), the number of school or preschool days of absenteeism, the duration and intensity of pain, the presence of nocturnal pain and vomiting. Scores ranged from 0 to16, with high scores indicating greater severity. According to this scale patients will be divided with dyspepsia into three groups: Mild (score <6), moderate (score 7-10) and severe (score >11)
Measured: 6 months
Secondary outcomes (1)
Effect of bee honey on recurrence of symptoms one month after stopping medications assessed by Modified Glasgow Dyspepsia Severity Score.
- Assessment of patients will be done at the 12th week of the study, patients in both groups will be reassessed and any recurrence of symptoms in the complete recovery patients or flare up of symptoms among those with partial recovery will be documented.
- Assessment of the severity of dyspepsia using "Modified Glasgow Dyspepsia Severity Score". It will be tried to evaluate the frequency of abdominal pain (predominant symptom), the number of school or preschool days of absenteeism, the duration and intensity of pain, the presence of nocturnal pain and vomiting. Scores ranged from 0 to16, with high scores indicating greater severity. According to this scale patients will be divided with dyspepsia into three groups: Mild (score <6), moderate (score 7-10) and severe (score >11)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start21 Jan 2022
- Primary completion21 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two groups; interventional and control groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mamdouh abdulmaksoud abdulrhman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209646
- Sponsor's protocol ID
- MS 513/ 2021
- Status last verified
- Feb 2023
- First submitted
- 11 Dec 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akhondi-Meybodi M, Aghaei MA, Hashemian Z. The role of diet in the management of non-ulcer dyspepsia. Middle East J Dig Dis. 2015 Jan;7(1):19-24.
PubMed 25628849Dehghani SM, Imanieh MH, Oboodi R, Haghighat M. The comparative study of the effectiveness of cimetidine, ranitidine, famotidine, and omeprazole in treatment of children with dyspepsia. ISRN Pediatr. 2011;2011:219287. doi: 10.5402/2011/219287. Epub 2011 Apr 5.
PubMed 22389770Febriani TB, Widowati T and Juffrie M Reducing dyspeptic symptoms in children: proton pump inhibitor vs. H2 receptor antagonist. Paediatrica Indonesiana. 2014; 54(4):198-201.
Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
PubMed 16678566Kim YS, Kim N. Functional Dyspepsia: A Narrative Review With a Focus on Sex-Gender Differences. J Neurogastroenterol Motil. 2020 Jul 30;26(3):322-334. doi: 10.5056/jnm20026.
PubMed 32606255Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.
PubMed 28092724Mohtashami R, Huseini HF, Heydari M, Amini M, Sadeqhi Z, Ghaznavi H, Mehrzadi S. Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial. J Ethnopharmacol. 2015 Dec 4;175:147-52. doi: 10.1016/j.jep.2015.09.022. Epub 2015 Sep 18.
PubMed 26386381Pesce M, Cargiolli M, Cassarano S, Polese B, De Conno B, Aurino L, Mancino N, Sarnelli G. Diet and functional dyspepsia: Clinical correlates and therapeutic perspectives. World J Gastroenterol. 2020 Feb 7;26(5):456-465. doi: 10.3748/wjg.v26.i5.456.
PubMed 32089623Samarghandian S, Farkhondeh T, Samini F. Honey and Health: A Review of Recent Clinical Research. Pharmacognosy Res. 2017 Apr-Jun;9(2):121-127. doi: 10.4103/0974-8490.204647.
PubMed 28539734Spiroglou K, Paroutoglou G, Nikolaides N, Xinias I, Giouleme O, Arsos G et al. Dyspepsia in childhood. Clinical manifestations and management. Annals of Gastroenterology. 2004; 17(2):173-180.
Taghvaei T, Bagheri-Nesami M and Nikkhah A. The Effect of Honey and Diet Education on Symptoms of Functional Dyspepsia: A Randomized Clinical Trial. Iranian Red Crescent Medical Journal. 2018; 20(8): e65557.
Wang YP, Herndon CC, Lu CL. Non-pharmacological Approach in the Management of Functional Dyspepsia. J Neurogastroenterol Motil. 2020 Jan 30;26(1):6-15. doi: 10.5056/jnm19005.
PubMed 31751504Yagi M, Homma S, Kubota M, Iinuma Y, Kanada S, Kinoshita Y, Ohtaki M, Yamazaki S, Murata H. The herbal medicine Rikkunshi-to stimulates and coordinates the gastric myoelectric activity in post-operative dyspeptic children after gastrointestinal surgery. Pediatr Surg Int. 2004 Jan;19(12):760-5. doi: 10.1007/s00383-003-1053-y. Epub 2004 Jan 9.
PubMed 14714134
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bee Honey as a Therapeutic Modality for Children With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05209646
- Acronym / sponsor ID
- MS 513/ 2021
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Functional dyspepsia in children, Bee honey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 26 Jan 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.
Functional dyspepsia is a constellation of diverse gastrointestinal disturbing symptoms with multifactorial feature, varying from upper abdominal bloating to nausea and vomiting, that are not attributable to organic causes after proper medical assessment. Treatment options are unsatisfactory due to the lack of identifiable pathophysiology as well as the pharmacological therapy are less effective, so using an additional reliable non-pharmacological therapy would be promising.
Bee honey has not only being used as food but also it has being used as an alternative medicine for its several benefits in different health aspects. This study will address the use of bee honey as an adjuvant therapy to functional dyspepsia in children under proper follow-up periods.
Detailed description
Functional dyspepsia (FD), among the most common gastrointestinal (GIT) disorders, is characterized by early satiation, postprandial fullness, epigastric pain, or epigastric burning in the absence of an organic or metabolic disease. FD is not a life-threatening serious illness, but its symptoms could persist; rather, they limit one's social life and reduce their quality of life. In addition, FD constitutes a serious disease burden worldwide because of its high prevalence.
Proton pump inhibitor (PPI) in the form of Omeprazole had the best result on all dyspeptic symptoms being relieved on children aged 3-18 years with dyspepsia.
Nonetheless, the efficacy of pharmacological therapies remains unsatisfactory and a considerable number of FD patients are refractory to conventional pharmacological treatments. Furthermore, low compliance of the traditional therapy can be observed in some FD patients as they would opt out from these pharmacological options because of the concerns on the side effects. In the absence of an approved drug to treat FD many patients seek person-centered, nonpharmacological approaches.
As the consumption of nutrients can moderate the sensors of the upper gastrointestinal tract movement, changes in diet can probably improve the symptoms of functional dyspepsia. Alternative and complementary medicine has also been proposed as a practical treatment for dyspepsia. Another substance used for treating this disorder is honey, which is economical and has a short treatment period. Many old sources have reported the use of honey for preventing stomach ulcers, gastritis, and gastroenteritis. Honey has a stimulating effect on the stomach nerves, which may be due to the antioxidant activity of honey. According to a study, the consumption of honey reduces the acidic activity of the stomach by 56%. Another study showed the effect of honey on the improved blood supply of stomach microscopic capillaries and it helped in the repair of ulcers. The symptoms of functional dyspepsia can also be improved through diet education. In various studies, most people have reported the onset or exacerbation of dyspepsia symptoms after eating. Unhealthy nutritional behaviors can exacerbate the symptoms of functional dyspepsia.
Adjuvant supplementation of honey based formulation of Nigella sativa can cause significant symptomatic improvement of patients with functional dyspepsia.
Honey is considered one of the most common foods having alleviating effects on non-ulcer dyspepsia.
In considerations of scarce knowledge in this field, health attributes of bee honey as a reliable therapy to improve the symptoms of functional dyspepsia in children, deserves seeking for.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups; interventional and control groups
| Arm | Type | Receives |
|---|---|---|
| Trial (Intervention) group | Experimental | Dietary Supplement: Bee honeyPatients will receive honey for 8 weeks in a dose of 30 ml undiluted honey per day divided as 5 ml honey 30 minutes before each meal six times daily. The honey will be kept in a closed glass container and away from light until the time of use. Each patient will be provided with a well-sealed container containing 210 ml honey each week. The honey used in the study will be a raw, unprocessed Clover honey collected from AL Mahala-Gharbia governorate, Egypt. The honey will be supplied directly from a beekeeper without heating or gamma irradiation |
| Control (Non-intervention) group | No intervention | –No honey will be given to this group |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- All patients between 8 and 18 years-old, based on Rome IV criteria that provide evidence-based definitions and classifications for so-called functional gastrointestinal disorders, such as functional dyspepsia in children and adolescents, with 1 or more of the following bothersome symptoms at least 4 days per month for at least 2 months:
- Postprandial fullness
- Early satiation
- Epigastric pain or burning not associated with defecation
- After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
Key exclusion criteria (5 listed)
- The presence of alarm symptoms and signs which might suggest underlying organic pathology as listed in Rome III criteria including: (Persistent right upper or right lower quadrant pain, dysphagia, persistent vomiting, gastrointestinal blood loss, nocturnal diarrhea, family history of inflammatory bowel disease, celiac disease, or peptic ulcer disease, pain that wakes the child from sleep, arthritis, perirectal disease, involuntary weight loss, deceleration of linear growth, delayed puberty or unexplained fever).
- Gastrointestinal tract surgery, one year post-operative.
- Diabetes mellitus
- Any debilitating disorder e.g. malignancy, severe malnutrition, renal failure, etc.
- Patients on medications that may produce GIT disorders e.g. aspirin, steroids or NSAIDs
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 |
|---|---|---|
| Bee honeypatients will receive honey for 8 weeks in a dose of 30 ml undiluted honey per day divided as 5 ml honey 30 minutes before each meal six times daily. The honey will be kept in a closed glass container and away from light until the time of use. Each patient will be provided with a well-sealed container containing 210 ml honey each week. The honey used in the study will be a raw, unprocessed Clover honey collected from AL Mahala-Gharbia governorate, Egypt. The honey will be supplied directly from a beekeeper without heating or gamma irradiation. | Dietary supplement | Trial (Intervention) group |
Primary outcome
Effect of bee honey on functional dyspepsia as an adjuvant therapy among dyspepsia suffering children assessed by Modified Glasgow Dyspepsia Severity Score in comparison to age and sex matched controls.
Time frame: 6 months
* Every week during the first 4 weeks of the study. Patients' response will be divided into complete recovery, partial improvement, no improvement or worsening of symptoms. At the 4th week of the study, those who completely recovered or partially improved will discontinue using PPI, while those with no improvement or worsening will continue on PPI and will be excluded * At the 8th week of the study, honey will be discontinued and reassessment will be done * Assessment of the severity of dyspepsia using "Modified Glasgow Dyspepsia Severity Score". It will be tried to evaluate the frequency of abdominal pain (predominant symptom), the number of school or preschool days of absenteeism, the duration and intensity of pain, the presence of nocturnal pain and vomiting. Scores ranged from 0 to16, with high scores indicating greater severity. According to this scale patients will be divided with dyspepsia into three groups: Mild (score <6), moderate (score 7-10) and severe (score >11)
1 secondary outcome
Effect of bee honey on recurrence of symptoms one month after stopping medications assessed by Modified Glasgow Dyspepsia Severity Score.
Time frame: 6 months
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 21 Feb 2023.
- Background: PubMed 25628849Akhondi-Meybodi M, Aghaei MA, Hashemian Z. The role of diet in the management of non-ulcer dyspepsia. Middle East J Dig Dis. 2015 Jan;7(1):19-24.
- Background: PubMed 22389770Dehghani SM, Imanieh MH, Oboodi R, Haghighat M. The comparative study of the effectiveness of cimetidine, ranitidine, famotidine, and omeprazole in treatment of children with dyspepsia. ISRN Pediatr. 2011;2011:219287. doi: 10.5402/2011/219287. Epub 2011 Apr 5.
- BackgroundFebriani TB, Widowati T and Juffrie M Reducing dyspeptic symptoms in children: proton pump inhibitor vs. H2 receptor antagonist. Paediatrica Indonesiana. 2014; 54(4):198-201.
- Background: PubMed 16678566Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.
- Background: PubMed 32606255Kim YS, Kim N. Functional Dyspepsia: A Narrative Review With a Focus on Sex-Gender Differences. J Neurogastroenterol Motil. 2020 Jul 30;26(3):322-334. doi: 10.5056/jnm20026.
- Background: PubMed 28092724Koppen IJ, Nurko S, Saps M, Di Lorenzo C, Benninga MA. The pediatric Rome IV criteria: what's new? Expert Rev Gastroenterol Hepatol. 2017 Mar;11(3):193-201. doi: 10.1080/17474124.2017.1282820. Epub 2017 Jan 24.
- Background: PubMed 26386381Mohtashami R, Huseini HF, Heydari M, Amini M, Sadeqhi Z, Ghaznavi H, Mehrzadi S. Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial. J Ethnopharmacol. 2015 Dec 4;175:147-52. doi: 10.1016/j.jep.2015.09.022. Epub 2015 Sep 18.
- Background: PubMed 32089623Pesce M, Cargiolli M, Cassarano S, Polese B, De Conno B, Aurino L, Mancino N, Sarnelli G. Diet and functional dyspepsia: Clinical correlates and therapeutic perspectives. World J Gastroenterol. 2020 Feb 7;26(5):456-465. doi: 10.3748/wjg.v26.i5.456.
- Background: PubMed 28539734Samarghandian S, Farkhondeh T, Samini F. Honey and Health: A Review of Recent Clinical Research. Pharmacognosy Res. 2017 Apr-Jun;9(2):121-127. doi: 10.4103/0974-8490.204647.
- BackgroundSpiroglou K, Paroutoglou G, Nikolaides N, Xinias I, Giouleme O, Arsos G et al. Dyspepsia in childhood. Clinical manifestations and management. Annals of Gastroenterology. 2004; 17(2):173-180.
- BackgroundTaghvaei T, Bagheri-Nesami M and Nikkhah A. The Effect of Honey and Diet Education on Symptoms of Functional Dyspepsia: A Randomized Clinical Trial. Iranian Red Crescent Medical Journal. 2018; 20(8): e65557.
- Background: PubMed 31751504Wang YP, Herndon CC, Lu CL. Non-pharmacological Approach in the Management of Functional Dyspepsia. J Neurogastroenterol Motil. 2020 Jan 30;26(1):6-15. doi: 10.5056/jnm19005.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bee honey in people with Functional Gastrointestinal Disorders, run by Ain Shams University at 1 site in Egypt.
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 7 inclusion and 5 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 21 Feb 2023. 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 Egypt. 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. 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?
Effect of bee honey on functional dyspepsia as an adjuvant therapy among dyspepsia suffering children assessed by Modified Glasgow Dyspepsia Severity Score in comparison to age and sex matched controls. (time frame: 6 months). 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 NCT05209646, which also lists 13 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 21 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.