An interventional study of Bee honey in Functional Gastrointestinal Disorders, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 129 are open to participants now.
This study's enrollment of 60 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
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Exclusion Criteria:
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
Dietary Supplement: Bee honey
No honey will be given to this group
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.
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)
Time frame: 6 months
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)
Time frame: 6 months
Plan to share: No
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Ain Shams University