Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study
Abstract Background Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing...
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| Format: | Article |
| Language: | English |
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BMC
2022-05-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-022-01058-4 |
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| author | Kate Lawrence Kyriaki Myrissa Miguel Toribio-Mateas Lori Minini Alice M. Gregory |
| author_facet | Kate Lawrence Kyriaki Myrissa Miguel Toribio-Mateas Lori Minini Alice M. Gregory |
| author_sort | Kate Lawrence |
| collection | DOAJ |
| description | Abstract Background Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing changes in the gut microbiota. A microbiome-targeted dietary intervention was developed, and its feasibility assessed. Methods A non-randomised feasibility study was conducted on nine non-medicated children with ADHD, aged 8–13 years (mean 10.39 years), using a prospective one-group pre-test/post-test design. Participants were recruited from ADHD support groups in London and took part in the 6-week microbiome-targeted dietary intervention, which was specifically designed to impact the composition of gut bacteria. Children were assessed pre- and post-intervention on measures of ADHD symptomatology, cognition, sleep, gut function and stool-sample microbiome analysis. The primary aim was to assess the study completion rate, with secondary aims assessing adherence, adverse events (aiming for no severe and minimal), acceptability and suitability of outcome measures. Results Recruitment proved to be challenging and despite targeting 230 participants directly through support groups, and many more through social media, nine families (of the planned 10) signed up for the trial. The completion rate for the study was excellent at 100%. Exploration of secondary aims revealed that (1) adherence to each aspect of the dietary protocol was very good; (2) two mild adverse events were reported; (3) parents rated the treatment as having good acceptability; (4) data collection and outcome measures were broadly feasible for use in an RCT with a few suggestions recommended; (5) descriptive data for outcome measures is presented and suggests that further exploration of gut microbiota, ADHD symptoms and sleep would be helpful in future research. Conclusions This study provides preliminary evidence for the feasibility of a microbiome-targeted dietary intervention in children with ADHD. Recruitment was challenging, but the diet itself was well-tolerated and adherence was very good. Families wishing to trial this diet may find it an acceptable intervention. However, recruitment, even for this small pilot study, was challenging. Because of the difficulty experienced recruiting participants, future randomised controlled trials may wish to adopt a simpler dietary approach which requires less parental time and engagement, in order to recruit the number of participants required to make meaningful statistical interpretations of efficacy. Trial registration ClinicalTrials.gov Identifier: NCT03737877 . Registered 13 November 2018—retrospectively registered, within 2 days of the first participant being recruited. |
| first_indexed | 2024-04-14T00:51:13Z |
| format | Article |
| id | doaj.art-e15fbadb549d4476819d31243f1cb4c7 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-04-14T00:51:13Z |
| publishDate | 2022-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-e15fbadb549d4476819d31243f1cb4c72022-12-22T02:21:48ZengBMCPilot and Feasibility Studies2055-57842022-05-018111510.1186/s40814-022-01058-4Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility studyKate Lawrence0Kyriaki Myrissa1Miguel Toribio-Mateas2Lori Minini3Alice M. Gregory4Department of Psychology & Pedagogic Science, Faculty of Sport, Allied Health and Performance Science, St Mary’s UniversityDepartment of Health Sciences, Faculty of Sport, Allied Health and Performance Science, St Mary’s UniversitySchool of Health and Education, Middlesex UniversityDepartment of Psychology & Pedagogic Science, Faculty of Sport, Allied Health and Performance Science, St Mary’s UniversityDepartment of Psychology, Goldsmiths, University of LondonAbstract Background Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing changes in the gut microbiota. A microbiome-targeted dietary intervention was developed, and its feasibility assessed. Methods A non-randomised feasibility study was conducted on nine non-medicated children with ADHD, aged 8–13 years (mean 10.39 years), using a prospective one-group pre-test/post-test design. Participants were recruited from ADHD support groups in London and took part in the 6-week microbiome-targeted dietary intervention, which was specifically designed to impact the composition of gut bacteria. Children were assessed pre- and post-intervention on measures of ADHD symptomatology, cognition, sleep, gut function and stool-sample microbiome analysis. The primary aim was to assess the study completion rate, with secondary aims assessing adherence, adverse events (aiming for no severe and minimal), acceptability and suitability of outcome measures. Results Recruitment proved to be challenging and despite targeting 230 participants directly through support groups, and many more through social media, nine families (of the planned 10) signed up for the trial. The completion rate for the study was excellent at 100%. Exploration of secondary aims revealed that (1) adherence to each aspect of the dietary protocol was very good; (2) two mild adverse events were reported; (3) parents rated the treatment as having good acceptability; (4) data collection and outcome measures were broadly feasible for use in an RCT with a few suggestions recommended; (5) descriptive data for outcome measures is presented and suggests that further exploration of gut microbiota, ADHD symptoms and sleep would be helpful in future research. Conclusions This study provides preliminary evidence for the feasibility of a microbiome-targeted dietary intervention in children with ADHD. Recruitment was challenging, but the diet itself was well-tolerated and adherence was very good. Families wishing to trial this diet may find it an acceptable intervention. However, recruitment, even for this small pilot study, was challenging. Because of the difficulty experienced recruiting participants, future randomised controlled trials may wish to adopt a simpler dietary approach which requires less parental time and engagement, in order to recruit the number of participants required to make meaningful statistical interpretations of efficacy. Trial registration ClinicalTrials.gov Identifier: NCT03737877 . Registered 13 November 2018—retrospectively registered, within 2 days of the first participant being recruited.https://doi.org/10.1186/s40814-022-01058-4ActigraphyAttention-deficit hyperactivity disorderADHDChildrenDietFeasibility study |
| spellingShingle | Kate Lawrence Kyriaki Myrissa Miguel Toribio-Mateas Lori Minini Alice M. Gregory Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study Pilot and Feasibility Studies Actigraphy Attention-deficit hyperactivity disorder ADHD Children Diet Feasibility study |
| title | Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study |
| title_full | Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study |
| title_fullStr | Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study |
| title_full_unstemmed | Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study |
| title_short | Trialling a microbiome-targeted dietary intervention in children with ADHD—the rationale and a non-randomised feasibility study |
| title_sort | trialling a microbiome targeted dietary intervention in children with adhd the rationale and a non randomised feasibility study |
| topic | Actigraphy Attention-deficit hyperactivity disorder ADHD Children Diet Feasibility study |
| url | https://doi.org/10.1186/s40814-022-01058-4 |
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