The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Stool frequency
研究概览
简要总结
This research aims to study the dual effectiveness of incorporating soluble fibre and osmotic carbohydrates (SOLOS), with or without restricting fructans and GOS, and present novel findings in managing GI symptoms in patients with functional bowel disorders with constipation. These findings may also support researchers and clinicians in shaping new dietary approaches in the management of general constipation symptoms.
详细描述
Aims: This retrospective clinical audit study aims to evaluate the effectiveness of dietary advice promoting increased intake of soluble fibre and poorly absorbed (osmotic) carbohydrates, with or without restriction of fructans and galacto-oligosaccharides (GOS), on adult patients (18-70 years old) with functional bowel disorders with constipation from the UK by comparing to baseline scores for severity and frequency of gastrointestinal symptoms and stool output.
Hypothesis
The dietary advice promoting increased intake of soluble fibre and osmotic sugars will produce a significant change from baseline in gastrointestinal symptoms and stool output in adult patients (18-70 years old) with functional bowel disorders with constipation from the UK.
Methodology: The study population will include all patients who have consulted with the Principal Investigator, a specialist gastroenterology dietitian between January 2021 and December 2025. All patients who have met the inclusion criteria will then form the research sample. Eligible subjects' data and study variables will be extracted from patient letters and clinical management records without direct patient contact. These study variables include the frequency and severity of the patients' symptoms at their initial appointment and follow-up appointment if available. Anthropometric data such as height and weight will also be obtained. The compiled data will then be analysed by conducting statistical tests, specifically the paired t-test, which will produce descriptive statistics that will interpret the effectiveness of the SOLOS diet on patients with functional bowel disorders with constipation.
Applications: To date, there has not been any study studying the dual effects of soluble fibre and osmotic carbohydrates consumption on alleviating constipation-related symptoms in patients with functional bowel disorders with constipation. Therefore, this research aims to present novel findings that can advance existing dietary management of functional bowel disorders with constipation. These results are expected to deepen understanding and research in food manufacturing and clinical nutrition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presented with symptoms of FC, IBS-C, or SIBO-C
- •Were aged 18 to 70 years old. (Research focus is on adult patients, excluding older adults and children)
- •Date of baseline (first) and follow-up appointments ranged from January 2021 to December 2025
- •Did not attend follow-up appointments (Data would be treated as "intention to treat" and data points were carried forward for conservative analysis).
排除标准
- •Had no history of constipation-related symptoms (Does not relate to research question's population or outcome)
- •Started treatment before January 2021
- •Were not due for follow-up before the end of December 2025
- •Symptom and stool data inadequately recorded
研究组 & 干预措施
Patients with Functional Constipation
干预措施: Diet (Other)
Patients with IBS-C or SIBO-C
干预措施: Diet (Other)
结局指标
主要结局
Stool frequency
时间窗: January 2021 to December 2025
Frequency of stool output per week
Stool form
时间窗: January 2021 to December 2025
Bristol Stool Form Scale
Gastrointestinal Symptom Frequency
时间窗: January 2021 to December 2025
Frequency of gastrointestinal symptom in a week, recorded as number of days out of 7 the symptom occurred over the past week.
Gastrointestinal Symptom Severity
时间窗: January 2021 to December 2025
Severity of symptoms in a week scored using Gastrointestinal Symptom Rating Scale (GSRS). Scores range from 0 (absent) to 3 (severe).
次要结局
未报告次要终点
研究者
Wilson Bridgette Jane
Assistant Professor
Singapore Institute of Technology
