Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT02888392
Brief Summary:
The proposed study will primarily demonstrate the efficacy of kiwifruit as a food intervention for the relief of constipation and associated symptoms in functionally constipated adults, and those with IBS-C. Secondary measures will show the consumption of kiwifruit will result in improvements in gastro-intestinal discomfort levels of adults with IBS-C.
Detailed Description:
The study is a randomised, single-blinded, cross-over design. Both target study populations (those with functional constipation, and the matched healthy control group) will complete the 16-week trial. Each study group will be randomly selected to either begin the first intervention period on the kiwifruit treatment or the psyllium treatment, and following the washout period will then receive the opposite treatment. Researchers and analysts will be blind as to as to the order of treatment individuals will receive. A dedicated treatment administrator will be assigned to provide the treatments to participants and liaise with them during the intervention phases.
All participants will be free living and required to maintain their normal dietary and lifestyle habits for the duration of the trial.
The primary outcome measure will be quantification of CSBM (complete spontaneous bowel movement). Secondary outcome measures will include additional stool frequency measures and other questionnaires.
Study:
NCT02888392
Study Brief:
Protocol Section:
NCT02888392